FDA Device Recall Z-0005-2014: PhotoMedex, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0005-2014.

Recall Res Number

Z-0005-2014

Recalling Firm / Manufacturer

PhotoMedex, Inc.

FEI Number

3000206133

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-01-04

Date Posted

2013-10-01

Date Terminated

2014-04-16

Product Code

GEX

Event Number

64454

Product Quantity

549

Product Description The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

Reason for Recall Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

Action Details The firm initiated their recall of these products beginning on January 4, 2013 by sending notification letters to their consignees via electronic mail and/or facsimile. Customers were asked to return the affected product for a replacement.

Distribution Pattern Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.

Code Information / Serial Numbers Lot number 226201

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
KEELER LTD. Registration: 1000391004 View Registration
COOK INCORPORATED Registration: 1000393132 View Registration
AngioDynamics, Inc. Registration: 1000523114 View Registration
ALL QUALITY & SERVICES, INC. Registration: 1000548922 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
BRASSELER U.S.A. DENTAL, LLC Registration: 1032227 View Registration
ACUDERM, INC. Registration: 1035236 View Registration
DORNIER MEDTECH AMERICA, INC. Registration: 1037955 View Registration
MEDICAL ENERGY, INC. Registration: 1038823 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
MEDTRONIC XOMED, INC. Registration: 1045254 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
LASER ENGINEERING, INC. Registration: 1060848 View Registration
ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
COOPERSURGICAL, INC. Registration: 1216677 View Registration
Covidien Registration: 1219930 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
Lightera, LLC Registration: 1221275 View Registration
LASER PERIPHERALS LLC. Registration: 1221543 View Registration
GEOTEC, INC. Registration: 1222773 View Registration
CYNOSURE, LLC Registration: 1222993 View Registration
SILHOUET-TONE USA Registration: 1225072 View Registration
PRODUCT RESOURCES, LLC. Registration: 1225450 View Registration
PIONEER OPTICS CO. Registration: 1226005 View Registration
FOCUS MEDICAL, LLC. Registration: 1226486 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
Medtek Skin Care, Inc. Registration: 1318319 View Registration
ANGIODYNAMICS, INC. Registration: 1319211 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
NORDENT MFG., INC. Registration: 1419489 View Registration
TRIMEDYNE, INC. Registration: 1419951 View Registration
Sterigenics U.S., LLC Registration: 1420032 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
ACCUMEDIX, INC. Registration: 1424785 View Registration
MedXL Registration: 1644312 View Registration
Steritec Services, LLC Registration: 1647149 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
MEDTRONIC NAVIGATION, INC. Registration: 1723170 View Registration
CAO GROUP, INC. Registration: 1725006 View Registration
Cook Incorporated Registration: 1820334 View Registration
Cook Incorporated Registration: 1825146 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
ALLERGAN SALES, LLC Registration: 2011068 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
DEN-MAT HOLDINGS, LLC Registration: 2018957 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
BIOLASE MG LLC Registration: 2027755 View Registration
MILLENNIUM DENTAL TECHNOLOGIES, INC. Registration: 2031763 View Registration
Strata Skin Sciences, inc. Registration: 2031934 View Registration
SPECIALTEAM Registration: 2032092 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
ERCHONIA CORPORATION Registration: 2032513 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
COLOPLAST MANUFACTURING US, LLC Registration: 2125050 View Registration
VASCULAR SOLUTIONS LLC Registration: 2134812 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
CLARUS MEDICAL, LLC. Registration: 2183911 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
Beaver-Visitec International, Inc Registration: 2247224 View Registration
DDC TECHNOLOGIES, INC. Registration: 2438558 View Registration
ACCUTOME, INC. Registration: 2521877 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
Peregrine Surgical, LLC. Registration: 2529392 View Registration
Covidien Registration: 2647580 View Registration
SHOFU DENTAL CORP. Registration: 2916735 View Registration
NIDEK INCORPORATED Registration: 2936921 View Registration
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL Registration: 2938071 View Registration
XINTEC CORPORATION Registration: 2938889 View Registration
Iridex Corporation Registration: 2939653 View Registration
RH USA, INC. Registration: 2953684 View Registration
SCITON, INC. Registration: 2953696 View Registration
CUTERA, INC. Registration: 2954354 View Registration
FIBEROPTIC FABRICATIONS Registration: 3000313549 View Registration
POLYMICRO TECHNOLOGIES, A SUBSIDIARY OF MOLEX Registration: 3001222017 View Registration
EL.EN. ELECTRONIC ENGINEERING SPA Registration: 3001431138 View Registration
VALTRONIC TECHNOLOGIES (Suisse) SA Registration: 3001605696 View Registration
SPARQTRON CORP. Registration: 3002736133 View Registration
STERIS SPA Registration: 3002806603 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
J. MORITA MFG. CORP. Registration: 3002807636 View Registration
NIDEK CO., LTD. HAMACHO PLANT Registration: 3002807715 View Registration
SOR VAN RADIATION LTD Registration: 3002808227 View Registration
FCI FRANCE CHIRURGIE INSTRUMENTATION Registration: 3002991496 View Registration
ESTETIQUE INC. USA Registration: 3003015433 View Registration
Meditech International Inc Registration: 3003082988 View Registration
LISA LASER PRODUCTS GMBH Registration: 3003168101 View Registration
WAVELIGHT GmbH Registration: 3003288808 View Registration
CERAMOPTEC GMBH Registration: 3003340844 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
NPA de México S. de R.L. de C.V. Registration: 3003542872 View Registration
ANGSTROM MFG., INC. Registration: 3003610374 View Registration
Laser Dental Innovations Registration: 3003610527 View Registration
ITAMAR MEDICAL Registration: 3003616071 View Registration
Innofiber Registration: 3003683459 View Registration
OPTICAL INTEGRITY, INC. Registration: 3003708273 View Registration
GYRUS ACMI, INC. Registration: 3003790304 View Registration
BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LI Registration: 3003899230 View Registration
Ryder Integrated Logistics, INC Registration: 3004069780 View Registration
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Registration: 3004096429 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
LUMENIS, LTD. Registration: 3004135191 View Registration
ALMA LASERS LTD. Registration: 3004167969 View Registration
AMERICAN MEDICAL ENDOSCOPY Registration: 3004361445 View Registration
AEROLASE CORPORATION Registration: 3004374705 View Registration
QUANTA SYSTEM, S.P.A. Registration: 3004378299 View Registration
ALMA LASERS, INC. Registration: 3004450661 View Registration
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED Registration: 3004475754 View Registration
LUTRONIC CORPORATION Registration: 3004483538 View Registration
Asclepion Laser Technologies GmbH Registration: 3004485166 View Registration
OPHTHALMED LLC Registration: 3004497289 View Registration
SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD Registration: 3004505220 View Registration
MEDICAL LASER TECHNOLOGIES LTD. Registration: 3004529369 View Registration
SNJ CO LTD Registration: 3004633032 View Registration
CYDEN LIMITED Registration: 3004635398 View Registration
ELTECH K-LASER S.R.L. Registration: 3004642415 View Registration
LASERING S.R.L. Registration: 3004710757 View Registration
ZIEMER OPHTHALMIC SYSTEMS AG Registration: 3004858034 View Registration
DENTSPLY SIRONA INC Registration: 3004884150 View Registration
BIOS S.R.L. Registration: 3004940677 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3005099803 View Registration
ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS Registration: 3005180774 View Registration
MEDICOL USA, INC Registration: 3005205318 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
R.H. ELECTRONICS LTD. Registration: 3005238200 View Registration
Mectron North America Registration: 3005282635 View Registration
Omni-Guide Holdings, Inc. Registration: 3005350457 View Registration
EUFOTON S.R.L. Registration: 3005403788 View Registration
DENTLIGHT INC. Registration: 3005515469 View Registration
SILHOUET-TONE CORPORATION Registration: 3005545844 View Registration
COOK MEDICAL LLC Registration: 3005580113 View Registration
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD Registration: 3005581016 View Registration
VIORA LTD. Registration: 3005695724 View Registration
MEDICAL QUANT USA Registration: 3005730446 View Registration
MILTA PKP-GIT Registration: 3005739661 View Registration
Beyond International Inc. Registration: 3005791808 View Registration
LIGHT INSTRUMENTS Ltd. Registration: 3005801723 View Registration
Spectrum Brands, Inc. (a Delaware Corporation) Registration: 3005855240 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
GoldenDent Registration: 3005972890 View Registration
TOTAL VEIN SYSTEMS Registration: 3005987567 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
Lutronic Aesthetics, Inc. Registration: 3006247712 View Registration
GOOTEN INNOLIFE CORPORATION Registration: 3006368133 View Registration
VENUS CONCEPT INC. Registration: 3006515340 View Registration
KARL STORZ SE & CO. KG Registration: 3006546082 View Registration
ESPANSIONE MARKETING SPA Registration: 3006546131 View Registration
BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD Registration: 3006555617 View Registration
SHENZHEN GSD TECH CO., LTD Registration: 3006580954 View Registration
A.R.C. LASER GMBH Registration: 3006617841 View Registration
THD SPA Registration: 3006680097 View Registration
AMO Manufacturing USA, LLC Registration: 3006695864 View Registration
SHARPLIGHT TECHNOLOGIES LTD. Registration: 3006716777 View Registration
Plexus Manufacturing Sdn .Bhd. Registration: 3006786907 View Registration
USR ELECTRONIC SYSTEMS (1987) LTD Registration: 3006807694 View Registration
STERIL VERONA s.r.l. Registration: 3006849754 View Registration
JEISYS MEDICAL INC. Registration: 3006985163 View Registration
WONTECH Co., Ltd. Registration: 3006985208 View Registration
QUASAR ENGINEERING LTD. Registration: 3007048256 View Registration
BEIJING ADSS DEVELOPMENT CO., LTD. Registration: 3007084556 View Registration
Vydence Medical Industria e Comercio Ltda Registration: 3007085226 View Registration
BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. Registration: 3007113239 View Registration
SHANGHAI APOLO MEDICAL TECHNOLOGY CO.,LTD. Registration: 3007120647 View Registration
Sterigenics SAS Registration: 3007156625 View Registration
LASEROPTEK Registration: 3007181527 View Registration
WEINERT Fiber Optics Inc. Registration: 3007336385 View Registration
BEIJING SYNTECH LASER CO., LTD. Registration: 3007535734 View Registration
WEIFANG MINGLIANG ELECTRONICS CO.,LTD. Registration: 3007549439 View Registration
Sanbor Medical Xiamen, Inc. Registration: 3007583504 View Registration
HYPERION MEDICAL Registration: 3007674911 View Registration
GYMMAX TECHNOLOGY SHENZHEN CO., LTD Registration: 3007689716 View Registration
LAMBDA SPA Registration: 3007689729 View Registration
COGMEDIX Registration: 3007712511 View Registration
ENDYMED MEDICAL LTD Registration: 3008085016 View Registration
LIGHTMED CORP. Registration: 3008156177 View Registration
INTERMEDIC ARFRAN, S.A. Registration: 3008206114 View Registration
OD-OS GMBH Registration: 3008252121 View Registration
XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD Registration: 3008393409 View Registration
M&T SRL Registration: 3008442971 View Registration
I-Tek Medical, Inc. Registration: 3008627763 View Registration
LIGHTSCALPEL INC Registration: 3008720474 View Registration
MEDIPLAST ISRAEL LTD Registration: 3008729892 View Registration
The Lotus Global Group, Inc. Registration: 3008776882 View Registration
I.C. MEDICAL, INC. Registration: 3008805497 View Registration
PSORIA-SHIELD INC Registration: 3008872264 View Registration
VENUS CONCEPT LTD. Registration: 3008915316 View Registration
Ryder Integrated Logistics, INC Registration: 3008925277 View Registration
NORSELD PTY. LTD. Registration: 3008965332 View Registration
Emvera Technologies, LLC Registration: 3009019578 View Registration
HA2 MEDIZINTECHNIK GMBH Registration: 3009039068 View Registration
ATENA (FROM THE IMCO GROUP) LTD Registration: 3009040934 View Registration
BEIJING GOLDENLASER DEVELOPMENT CO., LTD. Registration: 3009078366 View Registration
LIGHTWAVE Registration: 3009241253 View Registration
Ziemer Opthalmic Systems AG Registration: 3009298127 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
NOVIAN HEALTH INC. Registration: 3009383334 View Registration
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. Registration: 3009444646 View Registration
International Medical Lasers, Inc. Registration: 3009453258 View Registration
Oncore Manufacturing, LLC dba NEOTech Registration: 3009462521 View Registration
BEIJING HONKON TECHNOLOGIES CO., LTD. Registration: 3009488834 View Registration
W AND R INVESTMENTS, LLC Registration: 3009593803 View Registration
CIRTRONICS CORPORATION Registration: 3009649442 View Registration
Laser Marketing Group, LLC Registration: 3009736547 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
ADVANCED FIBER TOOLS GMBH Registration: 3009887511 View Registration
MONTERIS MEDICAL CORP Registration: 3009970070 View Registration
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD Registration: 3010027944 View Registration
MED-FIBERS, INC. Registration: 3010035831 View Registration
Photonica USA LLC Registration: 3010053203 View Registration
JANCO, INC. Registration: 3010060157 View Registration
CONVERGENT DENTAL Registration: 3010175098 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
WEIFANG KM ELECTRONICS CO., LTD Registration: 3010273372 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
HYPER PHOTONICS S.R.L. Registration: 3010281590 View Registration
ASSEMBLY CONTRACTS LTD Registration: 3010314781 View Registration
Philips Consumer Lifestyle B.V. Registration: 3010359222 View Registration
CLASSYS INC Registration: 3010363436 View Registration
ZOLAR TECHNOLOGY & MFG CO INC Registration: 3010364538 View Registration
INMODE LTD. Registration: 3010511300 View Registration
BIOTEC SRL Registration: 3010627091 View Registration
AdvaLight APS Registration: 3010683226 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
ESPANSIONE MARKETING SPA Registration: 3010724743 View Registration
HULASER, INC. Registration: 3010822033 View Registration
AMT ENGINEERING CO., LTD. Registration: 3010902869 View Registration
DC Altfeld - Procter & Gamble Registration: 3010912900 View Registration
INNOVAQUARTZ LLC Registration: 3010933841 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3010972758 View Registration
GERMAN MEDICAL ENGINEERING GMBH Registration: 3011024620 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
4190777 CANADA INC Registration: 3011302631 View Registration
OBERON GMBH FIBER TECHNOLOGIES Registration: 3011310540 View Registration
Adler MicroMed, Inc. Registration: 3011412640 View Registration
Solta Medical, Inc. Registration: 3011423170 View Registration
G.N.S NEOLASER LTD. Registration: 3011514163 View Registration
BISON MEDICAL CO., LTD Registration: 3011555967 View Registration
Shenzhen Kaiyan Medical Equipment Co., Ltd Registration: 3011644607 View Registration
LAUNCH DEVELOPMENT Registration: 3011657089 View Registration
FORMATK SYSTEMS LTD. Registration: 3011670002 View Registration
SHANGHAI SHENGGUANG SCIENCE & TECHNOLOGY CO., LTD Registration: 3011743768 View Registration
B.Y. MEDIMOR LTD Registration: 3011782009 View Registration
AZENA MEDICAL Registration: 3011877721 View Registration
PROCTER & GAMBLE DISTRIBUTING LLC, THE Registration: 3011964664 View Registration
FOREO INC Registration: 3012104022 View Registration
SANHE LASERCONN TECH CO., LTD. Registration: 3012125201 View Registration
Ryder Integrated Logistics, INC Registration: 3012133441 View Registration
GENER8 Registration: 3012157621 View Registration
Johnson & Johnson Surgical Vision, Inc. Registration: 3012236936 View Registration
Shenzhen Lifotronic Technology Co.,Ltd. Registration: 3012289707 View Registration
WUHAN LOTUXS TECHNOLOGY CO.,LTD. Registration: 3012294783 View Registration
LIFEPHOTONIC GMBH Registration: 3012301874 View Registration
KARL STORZ ENDOSCOPY CANADA LTD. Registration: 3012322232 View Registration
FINEMEC Co., Ltd Registration: 3012440264 View Registration
CLINICAL LASERTHERMIA SYSTEMS AB Registration: 3012452798 View Registration
IDS LTD Registration: 3012639861 View Registration
LIGHT GUIDE OPTICS INTERNATIONAL LTD. Registration: 3012669557 View Registration
MEDICREATIONS LLC Registration: 3012772112 View Registration
BEIJING GLOBALIPL DEVELOPMENT CO., LTD. Registration: 3012799115 View Registration
TAMUZ F.T.K. SOLUTIONS Registration: 3012911444 View Registration
IPG MEDICAL CORPORATION Registration: 3012980277 View Registration
Dymax, Corp. Registration: 3013041594 View Registration
LT Technology Limited Registration: 3013121972 View Registration
DBM Corporation USA Registration: 3013376016 View Registration
ADVANCE-ESTHETIC LLC Registration: 3013397886 View Registration
Viant San Antonio, Inc. Registration: 3013404959 View Registration
IVYLASER (BEIJING) TECHNOLOGY CO., LTD. Registration: 3013446079 View Registration
GUANGZHOU NIANSHENG BEAUTY EQUIPMENT CO., LTD. Registration: 3013503862 View Registration
Ellex Medical Pty Ltd Registration: 3013515803 View Registration
JIANGXI MEDEX TECHNOLOGY CO.,LTD Registration: 3013529876 View Registration
Wisdom Medical Technologies Registration: 3013532143 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
CARTESSA AESTHETICS Registration: 3013602304 View Registration
ZHENGZHOU PZ LASER SLIM TECHNOLOGY CO., LTD Registration: 3013613043 View Registration
LIGHTMED DENTAL TECHNOLOGY CORP. Registration: 3013619029 View Registration
SPECLIPSE, INC. Registration: 3013697074 View Registration
THE STANDARD CO., LTD. Registration: 3013734919 View Registration
Lutronic Corporation Registration: 3013789508 View Registration
PREFERRED DEPOT Registration: 3013917867 View Registration
BLUECORE COMPANY Co., Ltd. Registration: 3014144061 View Registration
Boston Scientific Medical Device (Malaysia) SDN BHD Registration: 3014222368 View Registration
GTI MEDICAL LTD Registration: 3014225468 View Registration
CLARTEIS Registration: 3014226003 View Registration
AMI INC. Registration: 3014253920 View Registration
WINGDERM ELECTRO-OPTICS LTD. Registration: 3014310779 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
LAMEDITECH CO., LTD. Registration: 3014384451 View Registration
BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD. Registration: 3014388884 View Registration
PROMOITALIA LLC Registration: 3014561425 View Registration
Wuhan DIMED LASER TECHNOLOGY CO., LTD. Registration: 3014577013 View Registration
The Beauty Tech Group Ltd Registration: 3014737458 View Registration
HIRONIC CO., LTD. Registration: 3014980461 View Registration
ELEMENIC CO., LTD. Registration: 3014980477 View Registration
ELESTA SPA Registration: 3015077548 View Registration
BOULDER BIOMED LLC Registration: 3015151147 View Registration
LMG LASERS COMERCIO IMPORTACAO E EXPORTACAO LTDA Registration: 3015167792 View Registration
Wuhan Pioon Technology Co.,Ltd. Registration: 3015262665 View Registration
Mito Red Light LLC Registration: 3015313684 View Registration
GOME OPTICAL LENS COMPANY LIMITED Registration: 3015392301 View Registration
NEAUVIA NORTH AMERICA, INC Registration: 3015433394 View Registration
BEIJING WINKONLASER TECHNOLOGY LIMITED Registration: 3015452693 View Registration
OTZ Partners, LLC Registration: 3015529593 View Registration
NORLASE APS Registration: 3015658550 View Registration
LASETECH, LLC Registration: 3015730775 View Registration
BERGER & KRAFT Registration: 3015779311 View Registration
CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.) Registration: 3015807001 View Registration
ALL QUALITY & SERVICES, INC. Registration: 3015907115 View Registration
Heager GmbH Registration: 3015976667 View Registration
VIS (SHANGHAI) TECHNOLOGY CO., LTD. Registration: 3016076077 View Registration
LUVO MEDICAL TECHNOLOGIES, INC. Registration: 3016076698 View Registration
ROCAMED SAM Registration: 3016096097 View Registration
SHANDONG HUAMEI TECHNOLOGY CO.,LTD. Registration: 3016170453 View Registration
Cocoon Medical International, Ltd Registration: 3016181563 View Registration
Norlase INC Registration: 3016405041 View Registration
HIGH TECHNOLOGY PRODUCTS, SLU Registration: 3016413636 View Registration
OSMUNDS Registration: 3016445722 View Registration
Sanhe LEFIS Electronics Co.,Ltd Registration: 3016453004 View Registration
HydraFacial LLC Registration: 3016453096 View Registration
Candela Corporation Registration: 3016496662 View Registration
FACE ONLINE STORE LLC Registration: 3016661372 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
Shenzhen Peninsula Medical Group Registration: 3016746323 View Registration
Beijing Sano Laser S&T Development Co, Ltd. Registration: 3016830208 View Registration
RAJA TRADING COMPANY, INC. Registration: 3017060146 View Registration
DERMAQUAL Registration: 3017065670 View Registration
Beijing Nubway S&T Co.,Ltd. Registration: 3017124433 View Registration
BIOLASE MG LLC Registration: 3017125161 View Registration
BEIJING SPIRITLASER SCIENCE & TECHNOLOGY CO., LTD. Registration: 3017132875 View Registration
AESTHETIC TECHNOLOGY LTD Registration: 3017140525 View Registration
Lira Center Inc Registration: 3017144492 View Registration
BEIJING SANHE TECH CO., LTD. Registration: 3017173524 View Registration
GIGAALASER COMPANY LTD. Registration: 3017181358 View Registration
BEIJING SUPERLASER TECHNOLOGY CO., LTD. Registration: 3017200975 View Registration
DJO, LLC Registration: 3017264244 View Registration
CYDEN Ltd Registration: 3017400436 View Registration
Itamar Medical Ltd. (Alon) Registration: 3017638059 View Registration
ACCURE ACNE, INC. Registration: 3017786046 View Registration
OXID CORPORATION Registration: 3017929928 View Registration
SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD. Registration: 3017954802 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
LTRA GLOBAL CO. LTD. Registration: 3018116888 View Registration
Lustre Skin Ltd Registration: 3018188770 View Registration
SHENZHEN SOGA TECHNOLOGY CO., LTD. Registration: 3018318562 View Registration
GEVASOL TECHNOLOGIES Registration: 3019252665 View Registration
BEIJING HUACHENG TAIKE TECHNOLOGY CO., LTD. Registration: 3019559090 View Registration
GUANGZHOU T&B BEAUTY EQUIPMENT CO., LTD. Registration: 3019705154 View Registration
Realton (Suzhou) Medical Technology Co., Ltd. Registration: 3019906161 View Registration
IPG MEDICAL CORPORATION Registration: 3020221089 View Registration
LUMENIS BE INC. Registration: 3020611964 View Registration
NORCO, INC. Registration: 3020756 View Registration
DAEJU MEDITECH ENGINEERING CO., LTD. Registration: 3020770009 View Registration
DERMATECH INNOVATIONS LLC Registration: 3020900954 View Registration
NANJING BESTVIEW LASER S&T CO.,LTD. Registration: 3021011208 View Registration
CORONADO AESTHETICS LLC Registration: 3021159346 View Registration
Hebei JT Medical Co.,Ltd Registration: 3021315370 View Registration
EVOSKIN LLC Registration: 3021334828 View Registration
Lumenis Be Ltd Registration: 3021349626 View Registration
BEIJING UNT TECHNOLOGY CO.,LTD Registration: 3021380980 View Registration
Acclaro Corporation Registration: 3021550489 View Registration
GLOWNAR AESTHETICS. LLC Registration: 3022327202 View Registration
BEIJING LASERTELL MEDICAL CO., LTD. Registration: 3023343409 View Registration
MEDMIX CO.,LTD Registration: 3023344923 View Registration
LEASEIR TECHNOLOGIES SLU Registration: 3023344928 View Registration
BEIJING PERFECTLASER TECHNOLOGY CO.,LTD Registration: 3023808190 View Registration
HAIDARI BEAUTY TECHNOLOGY (BEIJING) CO., LTD Registration: 3023850562 View Registration
InnoVoyce LLC Registration: 3024753061 View Registration
WORLD AESTHETIX LLC Registration: 3025104654 View Registration
OPTOMETRIC AESTHETICS, LLC Registration: 3025268687 View Registration
BEIJING JONTE LASER TECHNOLOGY CO., LTD Registration: 3025379728 View Registration
JR-MEDIZINTECHNIK GMBH & CO KG Registration: 3025482817 View Registration
RHEIN LASER TECHNOLOGIES CO., LTD. Registration: 3026038437 View Registration
Weifang Dragonfly Electronic Technology Co., Ltd. Registration: 3026294985 View Registration
ISKRA MEHANIZMI D.O.O. Registration: 3026360847 View Registration
TERMOSALUD S.L. Registration: 3026400760 View Registration
ZIAN MEDICAL, LLC. Registration: 3026540840 View Registration
LiteCure, LLC Registration: 3026668625 View Registration
Shandong Moonlight Electronics Tech Co.,Ltd. Registration: 3027605507 View Registration
TRIANGEL RSD LIMITED Registration: 3027605646 View Registration
SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD Registration: 3027619554 View Registration
B*G*MAKEOVERS ADVANCED SKIN CARE AND SPA Registration: 3027725665 View Registration
SANHE MEDITECH CO., LTD Registration: 3027851853 View Registration
The Beauty Tech Group LLC Registration: 3029083714 View Registration
MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA Registration: 3029897009 View Registration
MEDENCY SRL Registration: 3030090167 View Registration
K.P. IMPULSE GROUP INTERNATIONAL LTD. Registration: 3030125922 View Registration
RIVIC, LLC Registration: 3030230686 View Registration
CYDEN MEDICAL TECHNOLOGY (ZHEJIANG) CO., LTD Registration: 3030233762 View Registration
PRECISION IMPACTS LLC Registration: 3030418454 View Registration
XOD Inc Registration: 3030420005 View Registration
TROKA CANADA INC. Registration: 3030495752 View Registration
HEBEI NEWANGIE TECHNOLOGY CO., LTD Registration: 3030543531 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
FABINJECT LLC Registration: 3030979014 View Registration
LUNA AESTHETIC GROUP SL Registration: 3030979156 View Registration
SANHE JUMEI TECHNOLOGY CO.,LTD Registration: 3031233197 View Registration
HEBEI LUFEN TECH CO., LIMITED Registration: 3031233199 View Registration
BAODING TE'ANZHOU ELECTRONIC TECHNOLOGY CO.,LTD. Registration: 3031582430 View Registration
ROHRER AESTHETICS, INC. Registration: 3031944951 View Registration
HEBEI ZHEMAI TECHNOLOGY CO.,LTD Registration: 3032147807 View Registration
Enamel Pure Inc. Registration: 3032916575 View Registration
DAWELL MEDICAL, LLC Registration: 3033126947 View Registration
LIFE PRP Registration: 3033273466 View Registration
CURE POINT THERAPEUTICS, INC Registration: 3033274371 View Registration
SMEDTRUM MEDICAL TECHNOLOGY CO. LTD. Registration: 3033482500 View Registration
Cynosure Lutronic Technology Corporation Registration: 3033511105 View Registration
SRMC CO., LTD. Registration: 3033524191 View Registration
JEISYS MEDICAL NORTH AMERICA INC Registration: 3033715699 View Registration
REJUVA FRESH LLC Registration: 3033844600 View Registration
BEIJING MINGQIAO TECHNOLOGY CO. , LTD. Registration: 3033884002 View Registration
Guangzhou Enzoeys photoelectric Technology Co., Ltd. Registration: 3033891767 View Registration
BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD. Registration: 3033905238 View Registration
IDS LTD Registration: 3034246188 View Registration
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Registration: 3034630389 View Registration
VELABODY LLC Registration: 3034995492 View Registration
GENERAL AESTHETIC MANUFACTURING Registration: 3035375056 View Registration
TRIA LASER INC Registration: 3036240802 View Registration
BOSTON AESTHETICS INC Registration: 3036425107 View Registration
HEBEI KEYLASER SCI-TECH CO., LTD. Registration: 3037047060 View Registration
SOLAS MEDICAL LLC Registration: 3037874486 View Registration
Infinity Medical International LLC Registration: 3037966040 View Registration
MEDART TECHNOLOGY EUROPE Registration: 3038189188 View Registration
XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD. Registration: 3038197172 View Registration
CARL ZEISS MEDITEC AG (JENA) Registration: 3038356864 View Registration
ELIXIR MD INC Registration: 3038372243 View Registration
LUNA X INC Registration: 3038373471 View Registration
REVIVE REGENERATIVE INC. Registration: 3038715747 View Registration
D.E.A. PROJECT S.R.L. Registration: 3039396569 View Registration
FOSHAN ZIKE TECHNOLOGY CO., LTD. Registration: 3040278125 View Registration
FABRINET CO., LTD. Registration: 3040278150 View Registration
NSON CO., LTD. Registration: 3041275224 View Registration
OMAN MEDICAL BEAUTY MANUFACTURE LIMITED Registration: 3042228064 View Registration
BEIJING SUNRISE SCIENCE TECHNOLOGY LIMITED Registration: 3042255006 View Registration
MICRO-ENERGY MEDICAL TECHNOLOGY CO., LTD. Registration: 3042261306 View Registration
menovex Medical Technology (Shenzhen) Co., Ltd Registration: 3042262496 View Registration
AXICON TECHNOLOGIES LLC Registration: 3042641021 View Registration
C3 SELECT LLC Registration: 3042953831 View Registration
HEBEI MITA BIOTECHNOLOGY LIMITED Registration: 3043011436 View Registration
GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED Registration: 3043012074 View Registration
HEBEI MITA TECHNOLOGY LIMITED Registration: 3043012240 View Registration
BLINK BRIGHT MEDICAL, INC. Registration: 3043047259 View Registration
DEZHOU GLOBALIPL MEDICAL TECHNOLOGY CO., LTD. Registration: 3043127589 View Registration
GUANGDONG FUQIANG BEAUTY EQUIPMENT CO.,LIMITED Registration: 3043140693 View Registration
HEBEI TUOSITE TECHNOLOGY CO.,LTD Registration: 3043149902 View Registration
GUANGZHOU KONMISON TECHNOLOGY CO., LTD. Registration: 3043153468 View Registration
CHANGSHA GOMECY ELECTRONICS CO., LTD. Registration: 3043654467 View Registration
BEIJING BEAUTEMAX TECHNOLOGY LIMITED Registration: 3043657394 View Registration
Foshan Haiseer Electronic Technology Co., Ltd. Registration: 3043729119 View Registration
CPMT LASER USA LLC Registration: 3044175602 View Registration
RISU MEDICAL TECHNOLOGY CO., LTD. Registration: 3044905918 View Registration
Xi'an Taibo Laser Beauty Company Registration: 3044995573 View Registration
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG Registration: 8010349 View Registration
ZIMMER MEDIZINSYSTEME GMBH Registration: 8010720 View Registration
MEDART ApS Registration: 8021543 View Registration
BIOMETRIX LTD. Registration: 8030115 View Registration
NIDEK CO., LTD. Registration: 8030392 View Registration
PERIMED AB Registration: 8030885 View Registration
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Registration: 8030987 View Registration
VTech Communications Ltd Registration: 8040564 View Registration
MOOR INSTRUMENTS LTD. Registration: 8043564 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
HGR INSTRUMENTE GMBH Registration: 8044098 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
THE YOSHIDA DENTAL MFG. CO., LTD. Registration: 9611036 View Registration
DORNIER MEDTECH GMBH Registration: 9611388 View Registration
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Registration: 9611516 View Registration
ENRAF-NONIUS B.V. Registration: 9612147 View Registration
EDAP TMS France SA Registration: 9612448 View Registration
FOTONA D.O.O. Registration: 9613462 View Registration
SIRONA DENTAL SYSTEMS GMBH Registration: 9614977 View Registration
Carl Zeiss Meditec AG (Jena) Registration: 9615030 View Registration
Boston Scientific Limited Registration: 9616684 View Registration
QUANTEL MEDICAL Registration: 9680671 View Registration
Boston Scientific Limited Registration: 9681260 View Registration
WAVELIGHT GmbH Registration: 9710340 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0005-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer