FDA Device Recall Z-0006-2024: Fresenius Medical Care Holdings, Inc.

Trividia Health, Inc. Registration: 1000113657 View Registration

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics Registration: 1000307092 View Registration

BELLCO Srl Registration: 1000312731 View Registration

Baxter R&D Europe SPRL Registration: 1000359047 View Registration

Polimeros Formula de Tecate S.A de C.V Registration: 1000484830 View Registration

Arrow International CR, a.s. Registration: 1000563940 View Registration

Linvatec Corporation Registration: 1017294 View Registration

Cardinal Health Registration: 1017768 View Registration

Cardinal Health Registration: 1018120 View Registration

Sterigenics U.S., LLC Registration: 1018470 View Registration

BAXTER HEALTHCARE CORPORATION Registration: 1019003 View Registration

EXELINT INTERNATIONAL, CO. Registration: 1035907 View Registration

Sterigenics U.S., LLC Registration: 1036836 View Registration

ADVANCE MEDICAL DESIGNS, INC. Registration: 1037885 View Registration

DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration

WRIGHT MEDICAL TECHNOLOGY, INC. Registration: 1043534 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration

STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration

DeRoyal Industries, Inc. Registration: 1054241 View Registration

Sterigenics U.S. LLC Registration: 1054811 View Registration

DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration

NIPRO MEDICAL CORPORATION Registration: 1056186 View Registration

REMINGTON MEDICAL, INC. Registration: 1056553 View Registration

Sterigenics US LLC Registration: 1058584 View Registration

OWEN MUMFORD USA, INC. Registration: 1058602 View Registration

DeRoyal Industries, Inc. Registration: 1060680 View Registration

Sterigenics U.S., LLC Registration: 1061124 View Registration

INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration

MERCEDES MEDICAL LLC Registration: 1063851 View Registration

MEDONE SURGICAL, INC. Registration: 1064371 View Registration

ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration

PHARMA SUPPLY, INC. Registration: 1066444 View Registration

EmCyte Corporation Registration: 1066491 View Registration

CHARTER MEDICAL, LLC Registration: 1066733 View Registration

RHYTHMLINK INTERNATIONAL, LLC Registration: 1067162 View Registration

Beaver-Visitec International, Inc. Registration: 1211998 View Registration

Becton, DIckinson and Company Registration: 1213809 View Registration

Citra Labs LLC Registration: 1216032 View Registration

INTL. MEDICAL INDUSTRIES Registration: 1217831 View Registration

Boehringer Ingelheim Pharmaceuticals, Inc. Registration: 1219205 View Registration

ICU Medical, Inc. Registration: 1219611 View Registration

DEPUY ORTHOPAEDICS, INC. Registration: 1219655 View Registration

Covidien Registration: 1219930 View Registration

ARTHREX, INC. Registration: 1220246 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration

Millstone Medical Testing - CT, LLC Registration: 1222747 View Registration

SPECTRA MEDICAL DEVICES, LLC Registration: 1224960 View Registration

ETEX Corporation Registration: 1225112 View Registration

Fresenius Medical Care Renal Therapies Group, LLC Registration: 1225714 View Registration

R.K. Manufacturing Registration: 1226146 View Registration

MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration

F.M. HOWELL & CO. Registration: 1313700 View Registration

Sterigenics U.S., LLC Registration: 1319639 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration

CONMED CORPORATION Registration: 1320894 View Registration

CSL Behring LLC Registration: 1410248 View Registration

BAXTER HEALTHCARE CORPORATION Registration: 1416980 View Registration

ARGON MEDICAL DEVICES, INC. Registration: 1417485 View Registration

MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration

MEDELA LLC Registration: 1419937 View Registration

LSL HEALTHCARE Registration: 1420054 View Registration

MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration

CAREFUSION 2200, INC. Registration: 1423507 View Registration

Cardinal Health 200, LLC Registration: 1423537 View Registration

INTL. MEDSURG CONNECTION, INC. Registration: 1423625 View Registration

Sterigenics US LLC Registration: 1423662 View Registration

TRICOR SYSTEMS Registration: 1423929 View Registration

Isomedix Operations, Inc. Registration: 1424263 View Registration

Isomedix Operations, Inc. Registration: 1450662 View Registration

A-S MEDICATION SOLUTIONS LLC Registration: 1450743 View Registration

Liebel-Flarsheim Company LLC Registration: 1518293 View Registration

DEPUY SPINE, INC. Registration: 1526439 View Registration

Sterigenics US, LLC Registration: 1526534 View Registration

HEALTH CARE LOGISTICS, INC. Registration: 1530671 View Registration

ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration

MedXL Registration: 1644312 View Registration

RETRACTABLE TECHNOLOGIES, INC. Registration: 1647137 View Registration

Sterigenics US LLC Registration: 1649518 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration

DELTA HI-TECH, INC. Registration: 1721183 View Registration

MERIT MEDICAL SYSTEMS, INC. Registration: 1721504 View Registration

Sterigenics U.S., LLC Registration: 1721676 View Registration

ALLISON MEDICAL, INC. Registration: 1722458 View Registration

Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration

Eli Lilly and Company, Pharmaceutical Delivery Systems Registration: 1819470 View Registration

BIOMET, INC. Registration: 1825034 View Registration

ARKRAY FACTORY USA, INC. Registration: 1832816 View Registration

C+A TOOL ENGINEERING, INC. Registration: 1836357 View Registration

BECTON DICKINSON AND COMPANY Registration: 1911916 View Registration

Cardinal Health Registration: 1915484 View Registration

BD MEDICAL Registration: 1920898 View Registration

Cardinal Health Registration: 1921846 View Registration

MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration

SURGICAL INSTRUMENT MANUFACTURERS, LLC Registration: 1935627 View Registration

THE METRIX COMPANY Registration: 1937141 View Registration

Sterigenics US LLC Registration: 2011171 View Registration

Sterigenics U.S., LLC Registration: 2022435 View Registration

Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration

West Pharmaceutical Services AZ, Inc. Registration: 2025648 View Registration

ICU MEDICAL, INC. Registration: 2025816 View Registration

BREVET INC. Registration: 2025870 View Registration

BIOSEAL Registration: 2027062 View Registration

OSTEOMED Registration: 2027754 View Registration

MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 2029214 View Registration

Sterigenics U.S., LLC Registration: 2029275 View Registration

Synergy Health AST, LLC Registration: 2030598 View Registration

Isomedix Operations, Inc. Registration: 2030624 View Registration

Isomedix Operations, Inc Registration: 2032098 View Registration

Isomedix Operations Inc. Registration: 2032112 View Registration

MEDTRONIC MINIMED Registration: 2032227 View Registration

PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration

MICROMEDICS, INC. Registration: 2183425 View Registration

ORTHOFIX US LLC Registration: 2183449 View Registration

Isomedix Operations, Inc. Registration: 2183744 View Registration

ULTI MED, INC. Registration: 2183771 View Registration

BECTON DICKINSON Registration: 2243072 View Registration

NOVO NORDISK INC. Registration: 2244771 View Registration

ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration

Isomedix Operations Inc. Registration: 2246552 View Registration

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics Registration: 2249062 View Registration

OSTEOTECH, INC. Registration: 2249915 View Registration

DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration

PHOENIX MEDICAL PRODUCTS, INC. Registration: 2320767 View Registration

BUSSE HOSPITAL DISPOSABLES Registration: 2433012 View Registration

PACKAGING COORDINATORS, LLC Registration: 2517117 View Registration

MEDICAL COMPONENTS INC Registration: 2518902 View Registration

B. BRAUN MEDICAL INC. Registration: 2521402 View Registration

B. BRAUN US DEVICE MANUFACTURING LLC Registration: 2523676 View Registration

DSM Biomedical, Inc. Registration: 2530154 View Registration

PALL LIFE SCIENCES PUERTO RICO, LLC Registration: 2647898 View Registration

STRYKER PUERTO RICO, LLC. Registration: 2648666 View Registration

Baxter Healthcare of Puerto Rico LLC Registration: 2649614 View Registration

Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company Registration: 2650089 View Registration

BERKELEY BIOLOGICS LLC Registration: 2950190 View Registration

Q.I. MEDICAL, INC. Registration: 2950467 View Registration

GOLDSTAR MEDICAL INSTRUMENTS Registration: 3000126234 View Registration

NIPRO CORPORATION Registration: 3000247873 View Registration

IMPERIAL TRADING LIMITED Registration: 3000268902 View Registration

Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts Registration: 3000779542 View Registration

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Arthrex GmbH Registration: 3002579136 View Registration

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Pharma Packaging Solutions, LLC dba Tjoapack, LLC Registration: 3002763532 View Registration

Sterigenics Germany GmbH Registration: 3002807090 View Registration

SYNERGY HEALTH STERILISATION UK LTD Registration: 3002807315 View Registration

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KASH SALES INC. Registration: 3003120666 View Registration

MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration

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FARMACO QUIMICA NACIONAL, S.A. Registration: 3003755939 View Registration

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TERUMO (PHILIPPINES) CORPORATION Registration: 3003902955 View Registration

INNOVATIVE MEDICAL MANUFACTURING CO. Registration: 3003974574 View Registration

STRYKER SPINE Registration: 3004024955 View Registration

Jung Rim Medical Industrial Co., Ltd. Registration: 3004054016 View Registration

MILESTONE SCIENTIFIC, INC. Registration: 3004082685 View Registration

CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD. Registration: 3004099493 View Registration

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GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration

SHANGHAI CARELIFE INTERNATIONAL TRADING CO. LTD Registration: 3004143450 View Registration

Sharp Packaging Services, LLC Registration: 3004161147 View Registration

SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration

B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. Registration: 3004417597 View Registration

PREMIUM PLUS DENTAL SUPPLIES INC Registration: 3004425647 View Registration

HANSAmed Limited DBA Citagenix Registration: 3004431266 View Registration

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DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration

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LIFE SPINE Registration: 3004499989 View Registration

TRI-STATE DE MEXICO, S. DE R.L. DE C.V. Registration: 3004519921 View Registration

DEROYAL INTERCONTINENTAL, S.R.L. Registration: 3004605321 View Registration

PENTAFERTE ITALIA S.R.L. Registration: 3004756837 View Registration

GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3004911384 View Registration

LIFENET HEALTH Registration: 3005064037 View Registration

Novo Nordisk (China) Pharmaceuticals, Co. Ltd. Registration: 3005186124 View Registration

SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. Registration: 3005202235 View Registration

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TOP SURGICAL TAIWAN CORP. Registration: 3005301868 View Registration

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Nelipak Healthcare Packaging Registration: 3005581234 View Registration

Forsure Medical Products LLC. Registration: 3005609751 View Registration

AMSINO MEDICAL (KUNSHAN) CO., LTD. Registration: 3005669815 View Registration

JIANGSU CAINA MEDICAL CO., LTD Registration: 3005670221 View Registration

MHC Medical Products Registration: 3005798905 View Registration

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Welmed, Inc. Registration: 3005841027 View Registration

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OK BIOTECH CO., LTD. Registration: 3005862821 View Registration

Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration

TOTAL VEIN SYSTEMS Registration: 3005987567 View Registration

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RR DONNELLEY-SUPPLY CHAIN SOLUTIONS Registration: 3006371704 View Registration

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Arrow International C.R. a.s. Registration: 3006425876 View Registration

INNOMED, S.A. DE C.V. Registration: 3006498370 View Registration

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QLRAD Registration: 3006948745 View Registration

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CHIRANA T.INJECTA, A.S. Registration: 3008272066 View Registration

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EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration

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AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP Registration: 3016844398 View Registration

Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration

SAINT JONES MANAGEMENT LP EOOD Registration: 3016904853 View Registration

VASCULAR INTEGRITY, LLC Registration: 3016965628 View Registration

INSTYLLA, INC. Registration: 3017208642 View Registration

AZAC Group Registration: 3017494520 View Registration

RHINO MEDICAL SUPPLY INC Registration: 3017509841 View Registration

STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration

AMERICAN BRANDS LLC Registration: 3017654330 View Registration

YONG CHANG CO., LTD. Registration: 3017717188 View Registration

LIFELONG MEDITECH PRIVATE LIMITED Registration: 3017770710 View Registration

SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI Registration: 3017907716 View Registration

Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration

MPS PHARMA & MEDICAL, INC. Registration: 3018125942 View Registration

AmeriPac, inc. - 951 Mustang Dr Registration: 3018326554 View Registration

VAULT PARAGON GROUP, INC. Registration: 3018681450 View Registration

BETA BIONICS, INC. Registration: 3019004087 View Registration

Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration

CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration

W.L.MED CO., LTD. Registration: 3020138744 View Registration

BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration

Arthrex New Zealand Limited Registration: 3020704423 View Registration

PROCEDURE PRODUCTS, INC. Registration: 3020778 View Registration

Transmedic Philippines Inc. Registration: 3020899789 View Registration

VVT MED Ltd Registration: 3021067373 View Registration

Arthrex Colombia SAS Registration: 3021226419 View Registration

BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS) Registration: 3021336182 View Registration

BIOGENOMICS S.A.C. - BIOCELLS SURGICAL Registration: 3021393544 View Registration

Embecta Medical II LLC Registration: 3022699058 View Registration

MEDITEC TECHNOLOGY COMPANY LIMITED Registration: 3023174629 View Registration

Intelimas Corporation Registration: 3023228837 View Registration

Border Assembly S de RL de CV Registration: 3023851856 View Registration

embecta medical I LLC Registration: 3024508819 View Registration

CLAYENS Crystal Lake , LLC Registration: 3025432964 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration

STACLEAR, INC. Registration: 3026478941 View Registration

BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A. Registration: 3027242374 View Registration

RONCADELLE OPERATIONS SRL Registration: 3027338968 View Registration

Arthrex Chile SPA Registration: 3027339877 View Registration

TRUE DIAGNOSTICS, INC. Registration: 3027500452 View Registration

DLP Medical Products, Corp. Registration: 3027534634 View Registration

TOP-TEK TECHNOLOGY (VIETNAM) COMPANY LIMITED Registration: 3027694073 View Registration

PEGASUS IMPORTS Registration: 3029328631 View Registration

ASMOH USA INC Registration: 3029755538 View Registration

GUIDESTAR MEDICAL DEVICES INC. Registration: 3029960285 View Registration

HLB LIFE SCIENCE CO., LTD. Registration: 3030089798 View Registration

LINEAGE BIOMEDICAL, INC Registration: 3030201489 View Registration

GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration

PHARMCO MEDICAL BV Registration: 3030447506 View Registration

PALM MEDICAL INTERNATIONAL BV Registration: 3030626857 View Registration

BMMEDICAL Registration: 3031233007 View Registration

CARE LIVING DIAGNOSTICS INC Registration: 3031259044 View Registration

CONTROL MEDICAL TECHNOLOGY Registration: 3031788372 View Registration

DAMBO SRL Registration: 3031983053 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration

MEDI.PLAN GMBH & CO. KG Registration: 3033536319 View Registration

Merit Medical Australia Pty Ltd. Registration: 3033589330 View Registration

YANGZHOU MEDLINE INDUSTRY CO., LTD. Registration: 3034667025 View Registration

HUZHOU JUNDA INDUSTRY CO., LTD. Registration: 3034669683 View Registration

DePuy Synthes Sales Registration: 3034676720 View Registration

GAMAMED VASCULAR SYSTEMS INC. Registration: 3035111606 View Registration

Zimmer Biomet Pty Ltd Registration: 3035366890 View Registration

TKMD RWANDA LTD Registration: 3035455509 View Registration

SHENZHEN XIANGZHIDA TECHNOLOGY CO.,LTD. Registration: 3035785623 View Registration

PERFECT TW MEDICAL INDUSTRY (VN) CO., LTD Registration: 3036679495 View Registration

CMT HEALTH PTE. LTD. Registration: 3036722184 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration

MAYA MEDICAL TOP TRADE LTD. Registration: 3036773433 View Registration

BQ PLUS MEDICAL CO., LTD. Registration: 3036978618 View Registration

WENZHOU BAIYU GLASSES TECHNOLOGY CO.,LTD Registration: 3038220293 View Registration

CAMEDICAL TECHNOLOGY (CAMBODIA) CO., LTD. Registration: 3038294399 View Registration

TOC Logistics / SOL-MILLENIUM CANADA, INC. Registration: 3038356900 View Registration

PUREBRAND SLUTIONS LTD Registration: 3041276591 View Registration

POSEIDON MEDICAL TECHNOLOGY LLC Registration: 3042370483 View Registration

ONETOUCH MEDICAL, LLC Registration: 3042953454 View Registration

ZMI PHARMA Registration: 3042971905 View Registration

15445361 CANADA INC. Registration: 3043051314 View Registration

ZAPALIGN LLC Registration: 3043226252 View Registration

PT ALPHA MEDICAL TECHNOLOGY Registration: 3043603327 View Registration

HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD. Registration: 3043709866 View Registration

TOC Logistics / SOL-MILLENIUM CANADA, INC. Registration: 3044026004 View Registration

Yangzhou Xingwei Medical Technology Co. , LTD Registration: 3044994889 View Registration

TERUMO CORP. Registration: 8010026 View Registration

BAXTER SA Registration: 8010130 View Registration

HENKE-SASS WOLF, GMBH. Registration: 8010418 View Registration

ALMO-ERZEUGNISSE ERWIN BUSCH GMBH Registration: 8010674 View Registration

TRANSCOJECT GMBH Registration: 8010803 View Registration

CODAN MEDICAL APS. Registration: 8021538 View Registration

OWEN MUMFORD, LTD. Registration: 8021764 View Registration

SYNTHES GMBH / Synthes Produktions GmbH Registration: 8030965 View Registration

B. BRAUN MEDICAL AG Registration: 8031007 View Registration

JMS CO., LTD. Registration: 8031563 View Registration

SHINA CORP. Registration: 8040619 View Registration

BAXTER PRODUCTOS MEDICOS, LTDA. Registration: 8040700 View Registration

Nipro (Thailand) Corporation Limited Registration: 8041145 View Registration

BECTON DICKINSON MEDICAL (SINGAPORE) Registration: 8041187 View Registration

STERIS Schweiz AG Registration: 8043792 View Registration

BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. Registration: 9610048 View Registration

HOWMEDICA INTERNATIONAL S. DE R.L., Registration: 9610726 View Registration

B. BRAUN MELSUNGEN AG Registration: 9610825 View Registration

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. Registration: 9610847 View Registration

DEPUY CMW Registration: 9610921 View Registration

TOP CORPORATION Registration: 9610993 View Registration

Euroband Bioline LTD. Registration: 9611024 View Registration

FRIEDRICH DANIELS GMBH Registration: 9611390 View Registration

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Registration: 9611516 View Registration

AVENT S. de R.L. de C.V. Registration: 9611594 View Registration

Cardinal Health (Kenmex Medical Specialties) Registration: 9612030 View Registration

Vantive Manufacturing Pte. Ltd. Registration: 9612057 View Registration

ELCAM MEDICAL A.C.A.L. Registration: 9612152 View Registration

HTL-STREFA S.A. Registration: 9613304 View Registration

BECTON DICKINSON DE MEXICO Registration: 9614033 View Registration

B. BRAUN DOMINICAN REPUBLIC INC. Registration: 9614279 View Registration

ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD Registration: 9615588 View Registration

SISTEMAS MEDICOS ALARIS, S.A De C.V. Registration: 9616066 View Registration

Convertors de Mexico S. de R.L. de C.V Registration: 9616088 View Registration

SHINCHANG MEDICAL CO., LTD. Registration: 9616157 View Registration

DMC MEDICAL LTD. Registration: 9616679 View Registration

Takeda Manufacturing Austria AG Registration: 9616848 View Registration

STRYKER SPINE Registration: 9617544 View Registration

ICU MEDICAL DE MEXICO, S. de R.L. de C.V. Registration: 9617594 View Registration

ZHEJIANG MEDICINES & HEALTH PRODUCTS I/ E CO., LTD. Registration: 9680222 View Registration

Avent S. de R.L. de C.V. Registration: 9680425 View Registration

ALSHIFA MEDICAL PRODUCTS CO. (CJS) Registration: 9680597 View Registration

PALL NEWQUAY Registration: 9680602 View Registration

ARTIGLASS SRL Registration: 9680615 View Registration

Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration

TERUMO EUROPE N.V. Registration: 9681413 View Registration

SCANDINAVIAN HEALTH LTD. Registration: 9681538 View Registration

NOVO NORDISK A/S Registration: 9681821 View Registration

KOFU FACTORY OF TERUMO CORP. Registration: 9681835 View Registration

Medical Device Recall: Z-0006-2024

Recall Parameters & Description

Related Establishments / Registrations

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