FDA Device Recall Z-0169-2024: Covidien

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0169-2024.

Recall Res Number

Z-0169-2024

Recalling Firm / Manufacturer

Covidien

FEI Number

2936999

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-08-10

Date Posted

2023-11-01

Date Terminated

N/A

Product Code

CCW

Event Number

92895

Product Quantity

42,367

Product Description McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Reason for Recall Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.

Action Details On August 10, 2023 Medtronic ( Parent company of Covidien) issued an Urgent via UPS. Medtronic ask consignees to take the following actions: 1. Quarantine all unused product from the affected lots of McGRATH MAC 2 disposable laryngoscope blades. See attachment A for guidance on identifying potentially affected devices. 2. Return all unused product from the affected lots in your inventory to Medtronic as described on the Customer Confirmation Form. 3. Please complete and return the enclosed Customer Confirmation Form even if you do not have unused inventory. 4. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed. 5. Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic: . Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or . Call FDA (800) FDA-1088 . Call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1

Distribution Pattern US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Korea, Republic Of Malta Mayotte Netherlands New Zealand Norway Pakistan Poland Portugal Reunion Romania Spain Sweden Switzerland Turkmenistan United Arab Emirates

Code Information / Serial Numbers UDI: 10884521824386/ Lot # 22102001

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
HEINE OPTOTECHNIK GMBH & CO. KG. Registration: 1000379039 View Registration
TRI-TECH FORENSICS, INC. Registration: 1036781 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
RG Medical USA Registration: 1057358 View Registration
INFINIUM MEDICAL, INC. Registration: 1066427 View Registration
STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration
DILON TECHNOLOGIES INC Registration: 1125612 View Registration
KARL STORZ ENDOVISION, INC. Registration: 1221826 View Registration
GEOTEC, INC. Registration: 1222773 View Registration
ENDOCRAFT LLC. Registration: 1225968 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
WELCH ALLYN, INC. Registration: 1316463 View Registration
ELMED, INC. Registration: 1412854 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
Instrumed International Inc dba Avalign German Specialty Instruments Registration: 1421101 View Registration
Nissha Medical Technologies (Ohio), Inc. Registration: 1519132 View Registration
voss medical products Registration: 1643116 View Registration
SONTEC INSTRUMENTS, INC. Registration: 1720747 View Registration
Salaera, LLC d.b.a Maxtec Registration: 1722070 View Registration
KING SYSTEMS CORPORATION. Registration: 1824226 View Registration
ASPEN SURGICAL PRODUCTS, INC. Registration: 1836161 View Registration
JEDMED Instrument Company Registration: 1926681 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
Anesthesia Associates, Inc. Registration: 2022648 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
SPIRACLE TECHNOLOGY Registration: 2030745 View Registration
NIHON KOHDEN AMERICA, INC. Registration: 2080783 View Registration
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. Registration: 2085947 View Registration
TIDI PRODUCTS, LLC Registration: 2182318 View Registration
SHONEY SCIENTIFIC, INC. Registration: 2183650 View Registration
ACTEON, INC. Registration: 2243757 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
PROPPER MFG. CO., INC. Registration: 2410251 View Registration
Sklar Corporation Registration: 2431166 View Registration
NOVAMED-USA Registration: 2432320 View Registration
AMERICAN DIAGNOSTIC CORP. Registration: 2434008 View Registration
INSTRUMENTATION INDUSTRIES, INCORPORATED Registration: 2518436 View Registration
MED SAVER, INC. Registration: 2529846 View Registration
Covidien Registration: 2936999 View Registration
GOLDSTAR MEDICAL INSTRUMENTS Registration: 3000126234 View Registration
OPCOM INC. Registration: 3000279801 View Registration
medi-G GMBH Registration: 3001614464 View Registration
TECHNIMEN SKILLERS Registration: 3001620590 View Registration
Suzhou Meccan Import and Export Corp. Registration: 3001650535 View Registration
QUALITY CONCEPT (PVT) LTD. Registration: 3002090132 View Registration
MOUNT BLONCK TRADING Registration: 3002675176 View Registration
S.G. MANUFACTURERS Registration: 3002761766 View Registration
SABOKAY INDUSTRIES Registration: 3002769835 View Registration
G.A. SURGICAL (PVT) LTD. Registration: 3002807115 View Registration
INTERSURGICAL LTD. Registration: 3002807267 View Registration
USTOMED INSTRUMENTE GMBH & CO. KG Registration: 3002808270 View Registration
MIAN SHAHID CORP. Registration: 3002834291 View Registration
SPIGGLE & THEIS MEDIZINTECHNIK GMBH Registration: 3002858762 View Registration
DILIGENT MEDICAL SERVICES Registration: 3003032798 View Registration
BOMIMED INC. Registration: 3003213883 View Registration
Kreidler Medizintechnik GmbH Registration: 3003322138 View Registration
CONCISE ENTERPRISES Registration: 3003334541 View Registration
Integra LifeSciences Corporation Registration: 3003418325 View Registration
HILBRO INTERNATIONAL (PVT) LIMITED Registration: 3003431869 View Registration
HAFNER CHIRURGISCHE INSTRUMENTE Registration: 3003435550 View Registration
DR. FRIGZ INTERNATIONAL (PVT) LTD. Registration: 3003644849 View Registration
MedSource Labs, LLC Registration: 3003674698 View Registration
Garana Industries Private Limited Registration: 3003759558 View Registration
HARWOOD DESIGN, INC. Registration: 3003761012 View Registration
GYRUS ACMI, INC. Registration: 3003790304 View Registration
CADEX ELECTRONICS, INC. Registration: 3003800159 View Registration
HIVE INTERNATIONAL PVT LTD. Registration: 3003807268 View Registration
VITALTEC CORPORATION Registration: 3003851906 View Registration
ZAIN'S MEDICAL IMAGE Registration: 3003877407 View Registration
B. ALI IMPEX Registration: 3003882387 View Registration
Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
ENTER MEDICAL CORPORATION Registration: 3003902679 View Registration
AMBU Limited Registration: 3003924186 View Registration
BR SURGICAL LLC Registration: 3004001706 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
CENTRAL SURGICAL CO. PVT. LTD. Registration: 3004168759 View Registration
MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration
Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 View Registration
ANDERSEN CALEDONIA LTD Registration: 3004530184 View Registration
AMERICAN MEDICALS Registration: 3004552850 View Registration
Fischer Surgical Inc. Registration: 3004571672 View Registration
WASHINGTON SURGICAL INTERNATIONAL Registration: 3004598675 View Registration
INTEGRA LIFESCIENCES CORPORATION Registration: 3004608878 View Registration
Salter Labs Registration: 3004748541 View Registration
KASHMIR SURGICAL WORKS Registration: 3004765453 View Registration
PROACT MEDICAL LTD Registration: 3004863697 View Registration
NORTH AMERICAN RESCUE, LLC. Registration: 3005034064 View Registration
SHANGHAI MEDICAL INSTRUMENTS (GROUP) LTD. CORP. Registration: 3005067367 View Registration
MELPEX BEAUTY INSTRUMENTS Registration: 3005092287 View Registration
ECLERIS SRL Registration: 3005216736 View Registration
Heuer International (A division of GST Corporation Limited) Registration: 3005273623 View Registration
Weldon Instruments Registration: 3005418651 View Registration
PRODOL MEDITEC S.A. Registration: 3005450700 View Registration
Ambler Surgical, LLC Registration: 3005528784 View Registration
INNOVATIVE INNOVATIONS INC. Registration: 3005536872 View Registration
KUNSTSTOFF CHRISTEL GMBH & CO. KG Registration: 3005579585 View Registration
STAAN BIOMED ENGINEERING PRIVATE LIMITED Registration: 3005698350 View Registration
SIMEX MEDIZINTECHNIK GMBH Registration: 3005813597 View Registration
SURGIKARE Registration: 3006059835 View Registration
FLEXICARE MEDICAL (DONGGUAN) LTD. Registration: 3006061749 View Registration
WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. Registration: 3006087789 View Registration
FENTEXMEDICAL GMBH Registration: 3006154292 View Registration
MEDITEC DEVICES Registration: 3006389770 View Registration
Scope Medical Devices Private Limited Registration: 3006455037 View Registration
GPC MEDICAL LIMITED Registration: 3006513362 View Registration
KARL STORZ SE & CO. KG Registration: 3006546082 View Registration
OSI OPTOELECTRONICS (MEDICAL DIVISION) Registration: 3006713849 View Registration
Plexus Manufacturing Sdn .Bhd. Registration: 3006786907 View Registration
Hangzhou Fushan Medical Appliance Co., Ltd. Registration: 3006787036 View Registration
Biopsy Fine Cut Instruments Registration: 3006891796 View Registration
APOTHECARIES SUNDRIES MFG PVT LTD Registration: 3007123908 View Registration
Hayden Medical Inc Registration: 3007137643 View Registration
MODERN MEDICAL EQUIPMENT MANUFACTURING (QING YUAN) LTD Registration: 3007421149 View Registration
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center Registration: 3007481893 View Registration
EUSA GLOBAL LLC Registration: 3007532396 View Registration
TOTAL TITANIUM, INC. Registration: 3007583964 View Registration
SURGICON PVT LTD Registration: 3007597038 View Registration
READMED COMPANY LTD. Registration: 3007647244 View Registration
ALVI Expo Registration: 3007751820 View Registration
OBP Medical Corporation Registration: 3007789561 View Registration
Prodol Meditec Limited Registration: 3007817051 View Registration
SAFERLIFE PRODUCTS CO.,LTD. Registration: 3008264111 View Registration
PT OSI Electronics Registration: 3008305513 View Registration
CROWN SURGICAL CORP. Registration: 3008338766 View Registration
TIMES SURGICAL CO. Registration: 3008388245 View Registration
MOLDPRO INC. Registration: 3008520150 View Registration
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. Registration: 3008693658 View Registration
NOVO SURGICAL, INC. Registration: 3008770252 View Registration
SURGICRAFTS Registration: 3008808049 View Registration
MEED SKILLS SURGICAL Registration: 3008936260 View Registration
Eurofins STERIPAC GMBH Registration: 3009217531 View Registration
SWENGG CO Registration: 3009255580 View Registration
PANORAMA INTERNATIONAL. Registration: 3009340886 View Registration
Primo Medical Group, Inc Registration: 3009420598 View Registration
PREMIUM BRANDS GROUP, S.A Registration: 3009429841 View Registration
MEDSOURCE FACTORY,INC. Registration: 3009512503 View Registration
HNM Medical dba HNM TOTAL RECON Registration: 3009513193 View Registration
GEBRUDER RENGGLI, AG Registration: 3009538961 View Registration
MRIMed Inc. DBA: Quality Safety Tools Registration: 3009560891 View Registration
EPSILON MEDICAL DEVICES SDN BHD. Registration: 3009669249 View Registration
DADDY D PRO Registration: 3009703496 View Registration
NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD Registration: 3009747810 View Registration
ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration
TRINITY MEDICAL DEVICES INC. Registration: 3010042047 View Registration
FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD Registration: 3010149039 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
Salter Labs de Mexico de S.A. de C.V. Registration: 3010272829 View Registration
TRIBALCO Registration: 3010317211 View Registration
NAWAZ AND SONS Registration: 3010353847 View Registration
Zhejiang UE Medical Corp. Registration: 3010396739 View Registration
FOREMOUNT ENTERPRISE CO., LTD. Registration: 3010402691 View Registration
ENDO TECH INSTRUMENTS Registration: 3010455030 View Registration
DONGGUAN HONFIELD PRECISION PARTS CO., LTD Registration: 3010564249 View Registration
TONGLU WANHE MEDICAL INSTRUMENT CO., LTD. Registration: 3010611926 View Registration
DONGGUAN WORLDTOP TECHNOLOGY CO.,LTD Registration: 3010676356 View Registration
TRI-ANIM HEALTH SERVICES, INC. Registration: 3010683054 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
EVONOS GMBH & CO. KG Registration: 3010726901 View Registration
MediConcepts Technology (Shenzhen) Company Limited Registration: 3010806653 View Registration
SWANTIA MEDICAL PRIVATE LIMITED Registration: 3010829427 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
Plexus Electronica S. de R.L. de C.V.. Registration: 3011120183 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
VONCARE MEDICAL DEVICE CO LTD Registration: 3011307234 View Registration
SINNTECH MEDICAL (PRIVATE) LIMITED Registration: 3011371465 View Registration
PEAK MEDICAL LTD. Registration: 3011497859 View Registration
HAZEL ENTERPRISES Registration: 3011499367 View Registration
BRUETSCH TECHNOLOGY AG Registration: 3011543740 View Registration
PRO-MED (WUXI)IMP.& EXP.CO.,LTD. Registration: 3012002722 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
KARL STORZ ENDOSCOPY CANADA LTD. Registration: 3012322232 View Registration
JESCOPE LTD. Registration: 3012445994 View Registration
SANICURE BV Registration: 3012494290 View Registration
Integra Canada ULC Registration: 3012507533 View Registration
ICU Medical Nederland B.V. Registration: 3012542015 View Registration
Technimark El Paso Registration: 3012728206 View Registration
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD Registration: 3012797688 View Registration
BRITEMED TECHNOLOGY INC. Registration: 3012843412 View Registration
Arvato SE Registration: 3013247477 View Registration
EMPIRE SURGICAL INSTRUMENTS COMPANY Registration: 3013358456 View Registration
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Registration: 3013501110 View Registration
B&H SURGICAL INSTRUMENT Registration: 3013503739 View Registration
T.K. India Pvt. Ltd. Registration: 3013515223 View Registration
Dragon Medical Co.,Ltd Registration: 3013524663 View Registration
SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD. Registration: 3013528571 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD Registration: 3013687468 View Registration
TIANJIN MEDAN MEDICAL CORP. Registration: 3013735264 View Registration
Berger Surgical Medical Products GmbH Registration: 3013784566 View Registration
Anhui Shiyin Photoelectric Instrument Co., Ltd. Registration: 3013831261 View Registration
LONG LIFE SURGICAL INDUSTRIES Registration: 3013901429 View Registration
RENOVO, INC. Registration: 3014023545 View Registration
ADROIT SURGICAL LLC Registration: 3014129616 View Registration
SHENZHEN CORERAY TECHNOLOGY CO., LTD. Registration: 3014233600 View Registration
Dongguan Aubo Metal Products Co., Ltd. Registration: 3014317364 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
SHENZHEN BESDATA TECHNOLOGY CO.,LTD Registration: 3014498758 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
RHENUS SE & CO. KG Registration: 3014656749 View Registration
HEBEI VIMED MEDICAL DEVICE COMPANY, LTD. Registration: 3014680906 View Registration
SKILL TO TECH INTERNATIONAL Registration: 3014908171 View Registration
XI'AN HAIYE MEDICAL EQUIPMENT CO,.LTD. Registration: 3015139770 View Registration
CRIMSON INTERNATIONAL Registration: 3015143057 View Registration
Medline Industries, LP - Mexicali (MXC) Registration: 3015173212 View Registration
One-AI Healthcare, Inc Registration: 3015216264 View Registration
TEKMODE Registration: 3015351976 View Registration
MEISTER SURGICAL INSTRUMENTS Registration: 3015398570 View Registration
ARMATECH INTERNATIONAL Registration: 3015512299 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration
DONGGUAN ANOCA MEDICAL DEVICE CO., LTD. Registration: 3016195092 View Registration
WM&DG Registration: 3016634868 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
CREATE BIOTECH CO., LTD. Registration: 3016734145 View Registration
COMFORT SURGICAL INSTRUMENTS Registration: 3016965929 View Registration
JIANGSU YONGLE MEDICAL TECHNOLOGY CO., LTD. Registration: 3017166758 View Registration
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. Registration: 3017178358 View Registration
Flexicare Lanka (Pvt) Ltd Registration: 3017202422 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
INFIRMARY MEDICAL SUPPLIES Registration: 3019404837 View Registration
JIANGSU MOLE ELECTRONIC TECHNOLOGY CO., LTD Registration: 3019530907 View Registration
AIMD INC. Registration: 3019784580 View Registration
BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration
SENSORENDO MEDICAL TECHNOLOGY (ZHUHAI) CO., LTD. Registration: 3020984207 View Registration
Shenzhen Sanping Image Technology Co., Ltd. Registration: 3021031769 View Registration
GREEN OR LLC Registration: 3021477808 View Registration
ALIRA MEDICAL DEVICES LLC Registration: 3022320321 View Registration
Verathon Inc. Registration: 3022472 View Registration
SURGISCAPE Registration: 3022862651 View Registration
INKA SURGICAL INSTRUMENTS Registration: 3023657851 View Registration
ANESTEK CORP. Registration: 3024026674 View Registration
SHENZHEN ZHIXIN BIOMEDICAL TECHNOLOGY CO., LTD. Registration: 3025349182 View Registration
IntuBlade Co. Registration: 3026201231 View Registration
DOCTOR DEVICES Registration: 3027187888 View Registration
MADINA SURGICAL WORKS Registration: 3027556548 View Registration
ZHONGSHAN WESEE MEDITECH CO., LTD. Registration: 3027655341 View Registration
Paras Surgico Factory Registration: 3027847726 View Registration
CHOOSE SURGICAL INSTRUMENTS Registration: 3029082594 View Registration
STELLMACHER INSTRUMENTS INC Registration: 3029754081 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
ENDONEST MEDICAL SYSTEMS LLP Registration: 3030516433 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
HANGZHOU ENDO MEDICAL INSTRUMENT CO.,LTD Registration: 3030839824 View Registration
VOLGO CARE INTERNATIONAL (PRIVATE) LIMITED Registration: 3031564283 View Registration
Medline ReNewal Registration: 3032391 View Registration
HEXAMED PVT LTD Registration: 3032747418 View Registration
OPCOM MEDICAL INC. Registration: 3033010858 View Registration
Zhuhai Pusen Medical Technology Co., Ltd. Registration: 3036978610 View Registration
PURE NOVAMED INC Registration: 3038087139 View Registration
JAY-MED Registration: 3039414397 View Registration
ENDOSEMIO CO., LTD. Registration: 3042158672 View Registration
VITAL AIR FZCO Registration: 3042888274 View Registration
Medsniper S.r.l. Registration: 3043585862 View Registration
ZHUHAI WESEE MEDITECH CO., LTD Registration: 3045010519 View Registration
BOEN HEALTHCARE CO., LTD. Registration: 3045058049 View Registration
MEDICON, E.G. Registration: 8010099 View Registration
RUDOLF MEDICAL GMBH + CO. KG Registration: 8010298 View Registration
SCHMID MEDIZINTECHNIK GMBH Registration: 8010374 View Registration
HENKE-SASS WOLF, GMBH. Registration: 8010418 View Registration
Kirchner & Wilhelm GmbH + Co.KG Registration: 8010427 View Registration
RUDOLF RIESTER GMBH Registration: 8010482 View Registration
NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH Registration: 8010704 View Registration
VBM MEDIZINTECHNIK GMBH Registration: 8010939 View Registration
Covidien Registration: 8020893 View Registration
Timesco Healthcare Ltd Registration: 8021788 View Registration
FLEXICARE MEDICAL LTD. Registration: 8021995 View Registration
SOUTHMEDIC, INC. Registration: 8022032 View Registration
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. Registration: 8030673 View Registration
GLORIOUS MERCANTILE CORP. (PVT) LTD. Registration: 8040263 View Registration
Falcon Surgical Co. (Pvt.) Ltd. Registration: 8040278 View Registration
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD. Registration: 8040510 View Registration
HILBRO (PVT) LTD. Registration: 8040884 View Registration
GALEMED CORP. Registration: 8043316 View Registration
SCHOELLY FIBEROPTIC, GMBH Registration: 8043903 View Registration
PENLON LTD. Registration: 9610531 View Registration
AESCULAP AG Registration: 9610612 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
Ambu A/S Registration: 9610691 View Registration
OLYMPUS WINTER & IBE GMBH Registration: 9610773 View Registration
O-TWO MEDICAL TECHNOLOGIES, INC. Registration: 9610861 View Registration
HILBRO INSTRUMENTS (PVT) LTD. Registration: 9611062 View Registration
RICHARD WOLF GMBH Registration: 9611102 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
DIMEDA INSTRUMENTE GMBH Registration: 9611283 View Registration
Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
GIMMI GMBH Registration: 9612074 View Registration
SAHIROUN (PVT) LTD. Registration: 9613073 View Registration
WIN WINGS CORP. Registration: 9613079 View Registration
TECNO INSTRUMENTS (PVT.) LTD. Registration: 9613563 View Registration
NARANG MEDICAL, LTD. Registration: 9613910 View Registration
Gesco Healthcare Private Limited Registration: 9613926 View Registration
SGS EXPORT INTL. Registration: 9614069 View Registration
MEDICAL DEVICES (PVT) LTD. Registration: 9614084 View Registration
STONE INSTRUMENTS CO. Registration: 9614093 View Registration
VERATHON MEDICAL (CANADA) ULC. Registration: 9615393 View Registration
ASANUS MEDIZINTECHNIK GMBH Registration: 9616250 View Registration
HEADSTAR MEDICAL PRODUCTS CO., LTD Registration: 9616354 View Registration
OPTOMIC ESPANA, S.A. Registration: 9617248 View Registration
MARYAM TRADING Registration: 9680002 View Registration
STERIS Applied Sterilization Technologies ULC Registration: 9680143 View Registration
UNITED POLY ENGINEERING PVT. LTD. Registration: 9680168 View Registration
MEDESY srl Registration: 9680244 View Registration
HOSPITAL EQUIPMENT MFG. CO. Registration: 9680411 View Registration
CM INSTRUMENTE GMBH Registration: 9680518 View Registration
MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. Registration: 9680721 View Registration
INTEGRA MICROFRANCE SAS Registration: 9680837 View Registration
MACHIDA ENDOSCOPE CO., LTD. Registration: 9681246 View Registration
Covidien Registration: 9681384 View Registration
ULTRA SURGICAL (PVT.) LTD Registration: 9681540 View Registration
SURJEX Registration: 9681622 View Registration
Besmed Health Business Corporation Registration: 9710567 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-0169-2024

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer