Device recalls

Device recalls: 39,635 FDA enforcement reports

Every medical device recall the FDA has published since 2012. What was wrong, how bad the agency judged it, and where the product went.

39,635Recall reports
3,617Class I
13,720Still ongoing
2,776Firms named

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReportsShare
Class II34,99288.3%
Class I3,6179.1%
Class III1,0252.6%
Not Yet Classified10.0%

By year reported

YearReports
20121,310
20132,249
20143,059
20152,495
20163,246
20172,615
20183,757
20192,801
20203,055
20212,303
20222,192
20232,477
20243,394
20252,908
20261,774
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

By firm

Pages exist for 276 firms with 25 or more reports on file. Below that there is not enough on the record to say anything.

Zimmer Biomet, Inc.875 MEDLINE INDUSTRIES, LP - Northfield812 Siemens Medical Solutions USA, Inc796 Customed, Inc682 Siemens Healthcare Diagnostics, Inc.662 ICU Medical, Inc.640 Boston Scientific Corporation629 Medline Industries, LP480 Arrow International Inc478 GE Healthcare, LLC475 Zimmer, Inc.446 Biomerieux Inc422 Olympus Corporation of the Americas414 Philips North America Llc404 B. Braun Medical, Inc.401 Baxter Healthcare Corporation375 Covidien LLC340 Beckman Coulter Inc.330 Windstone Medical Packaging, Inc.324 Philips Medical Systems (Cleveland) Inc315 Smiths Medical ASD Inc.293 Cardinal Health 200, LLC276 Cook Inc.264 The Anspach Effort, Inc.261 Smith & Nephew, Inc.258 Intuitive Surgical, Inc.257 Maquet Cardiovascular, LLC252 Biomet, Inc.250 Stryker Endoscopy238 Howmedica Osteonics Corp.232 Resource Optimization & Innovation Llc228 DeRoyal Industries Inc226 Biomet 3i, LLC222 Ortho-Clinical Diagnostics221 Integra LifeSciences Corp.217 Exactech, Inc.211 Medtronic Vascular211 Terumo Cardiovascular Systems Corporation204 Teleflex Medical204 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.203 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)198 Beaver Visitec International, Inc.194 American Contract Systems, Inc.190 Becton Dickinson & Co.185 Becton Dickinson & Company178 CareFusion 303, Inc.173 AVID Medical, Inc.169 GE Medical Systems, LLC168 Synthes (USA) Products LLC164 Stryker Instruments Div. of Stryker Corporation161 Philips Electronics North America Corporation160 DePuy Orthopaedics, Inc.155 Centurion Medical Products Corporation152 Atrium Medical Corporation150 Fresenius Medical Care Holdings, Inc.148 Merit Medical Systems, Inc.144 Valorem Surgical LLC144 TELEFLEX LLC140 Bard Peripheral Vascular Inc139 Philips Ultrasound, Inc132 Roche Diagnostics Operations, Inc.127 Covidien, LP126 Philips North America126 Mckesson Medical-Surgical Inc. Corporate Office119 C.R. Bard Inc117 Elekta, Inc.116 RAYSEARCH LABORATORIES AB115 Aomori Olympus Co., Ltd.113 Steris Corporation112 Carefusion 2200 Inc110 Medtronic Perfusion Systems110 Stryker Corporation110 Stryker Neurovascular109 Ameditech Inc109 Medtronic Inc.109 Hospira Inc.108 Xeridiem Mediem Medical Devices Inc105 Medline Industries Inc104 Encore Medical, LP99 Angiodynamics, Inc.99 Zimmer GmbH99 Medtronic Neuromodulation98 Edwards Lifesciences, LLC95 Merge Healthcare, Inc.93 Philips Respironics, Inc.93 Stradis Medical, LLC dba Stradis Healthcare93 GET TESTED INTERNATIONAL AB92 Medtronic Navigation, Inc.91 ConMed Corporation91 Zimmer Manufacturing B.V.91 American Surgical Company91 Ortho-Clinical Diagnostics, Inc.90 GE Healthcare89 Jiangsu Shenli Medical Production Co., Ltd.88 Stryker Howmedica Osteonics Corp.87 Baxter Healthcare Corp.86 Carestream Health Inc.86 Remel Inc86 ROi CPS LLC86 Medtronic Sofamor Danek USA Inc85 Cook Incorporated85 CooperSurgical, Inc.83 Stryker Medical Division of Stryker Corporation80 LumiQuick Diagnostics Inc.80 Randox Laboratories Ltd.79 Philips Medical Systems Nederlands79 Abiomed, Inc.79 Wright Medical Technology, Inc.78 Draeger Medical, Inc.78 Angiodynamics Inc. (Navilyst Medical Inc.)78 Tosoh Bioscience Inc74 Cardinal Health73 Navilyst Medical, Inc73 Hobbs Medical, Inc.73 Heartware, Inc.72 Karl Storz Endoscopy71 Zavation71 Ethicon, Inc.70 LeMaitre Vascular, Inc.70 Stryker GmbH68 Datascope Corporation67 Datascope Corp.67 Alcon Research LLC67 Microbiologics Inc66 Nobel Biocare Usa Llc66 Stryker Sustainability Solutions65 Philips Medical Systems, Inc.65 Waldemar Link GmbH & Co. KG (Mfg Site)64 Busse Hospital Disposables, Inc.63 Maquet Cardiovascular Us Sales, Llc62 Vyaire Medical62 Aesculap Implant Systems LLC61 Codman & Shurtleff, Inc.59 International Medsurg Connection, Inc.59 Abbott Laboratories58 Avanos Medical, Inc.57 Synthes USA HQ, Inc.56 Toshiba American Medical Systems Inc56 COVIDIEN MEDTRONIC55 Ethicon Endo-Surgery Inc54 ConvaTec, Inc53 Cook Medical Incorporated53 SEDECAL SA53 Sorin Group USA, Inc.52 DePuy Mitek, Inc., a Johnson & Johnson Co.51 St Jude Medical Inc.51 Stradis Healthcare, LLC.51 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)50 Linkbio Corp.50 Alere San Diego, Inc.49 Medtronic MiniMed, Inc.49 Skeletal Kinetics, Llc49 Canon Medical System, USA, INC.49 Hologic, Inc48 GE OEC Medical Systems, Inc48 Argon Medical Devices, Inc48 Halyard Health, Inc48 Bausch & Lomb Inc Irb48 CME America, LLC48 Getinge Usa Sales Inc48 Riverpoint Medical, LLC47 Medtronic47 Oridion Medical 1987 Ltd.47 ARROW INTERNATIONAL, LLC47 Alphatec Spine, Inc.46 Respironics California, LLC46 BioMerieux SA45 Physio-Control, Inc.43 Synthes, Inc.43 Degania Silicone, Ltd.43 LivaNova USA Inc.43 Abbott Medical43 Roche Molecular Systems, Inc.42 EXP Pharmaceutical Services Corp42 BioFire Diagnostics, LLC42 Maquet Medical Systems USA41 Ventana Medical Systems Inc41 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING41 Leica Microsystems, Inc.40 Aesculap, Inc.40 Landauer40 Oscor, Inc.39 Cordis Corporation39 3M Company - Health Care Business39 Alcon Research, Ltd.39 Brainlab AG39 Mindray DS USA, Inc. dba Mindray North America39 Roche Diagnostics Corporation39 Luminex Corporation39 K2M, Inc39 Medical Components, Inc dba MedComp38 Instrumed International, Inc.38 Bard Access Systems Inc.38 Instrumentation Laboratory38 Invacare Corporation37 Smith & Nephew, Inc. Endoscopy Division37 Abbott Vascular37 Hill-Rom, Inc.37 Synergetics Inc37 Fujifilm Medical Systems U.S.A., Inc.37 Microvention, Inc.37 Burlington Medical, LLC37 BioPro, Inc.37 NuVasive Inc36 Philips Healthcare Inc.36 Advanced Sterilization Products36 DePuy Spine, Inc.36 Ion Beam Applications S.A.36 Civco Medical Instruments Co. Inc.36 Becton, Dickinson and Company, BD Biosciences35 ConforMIS, Inc.34 Ivoclar Vivadent, Inc.34 Orthofix Srl34 SpineFrontier, Inc.33 Medtronic MiniMed33 ZOLL Circulation, Inc.33 CooperVision Inc.33 Custom Healthcare Systems, Inc.33 MicroPort Orthopedics Inc.33 Zimmer Dental Inc33 Implant Direct Sybron Manufacturing, LLC33 Inpeco S.A.33 The Metrix Company33 Pentax of America Inc33 Philips Medical Systems Gmbh, DMC33 Abbott Laboratories, Inc32 Medtronic Neurosurgery32 American Medical Systems Innovation Center - Silicon Valley32 TELEFLEX MEDICAL INC32 Family Dollar Stores, Llc.32 Instrumentation Laboratory Co.31 Biosense Webster, Inc.31 Abbott Point Of Care Inc.31 NxStage Medical, Inc.31 Haemonetics Corporation31 Orthofix, Inc31 Aizu Olympus Co., Ltd.31 Integra LifeSciences Corp. (NeuroSciences)31 Trumpf Medical Systems, Inc.30 Applied Medical Resources Corp30 Spacelabs Healthcare Inc30 Abbott Molecular, Inc.30 Sklar Instruments30 Stryker Spine29 Integra LifeSciences Corporation29 Globus Medical, Inc.29 Roche Diabetes Care, Inc.29 Ossur H / F29 Dexcom, Inc.29 W L Gore & Associates, Inc.29 The Binding Site Group, Ltd.29 DAYE (ANNE'S DAY LTD)29 Zimmer Surgical Inc28 Coloplast Manufacturing US, LLC28 Arthrex, Inc.28 Universal Meditech Inc.28 Mako Surgical Corporation27 Siemens Healthcare Diagnostics27 GE Medical Systems China Co., Ltd.27 Cardinal Health Inc.27 Winco Mfg., LLC26 Shimadzu Medical Systems26 Medtronic Xomed, Inc.26 Biomet U.K., Ltd.26 OrthoPediatrics Corp26 Diagnostica Stago, Inc.26 Pentax Medical Company26 BIOTRONIK Inc26 Datex-Ohmeda, Inc.26 Radiometer America Inc25 Fresenius Medical Care Renal Therapies Group, LLC25 Fresenius Kabi USA, LLC25 Stryker Leibinger GmbH & Co. KG25 Radiometer Medical ApS25 CAREFUSION25 ASP Global, LLC. dba Anatomy Supply Partners, LLC.25
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.