Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 1, 2021 | SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic... | There is a potential for distal tip dislodgement or separation. | Class II | Cordis Corporation |
| Oct 1, 2021 | SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic... | There is a potential for distal tip dislodgement or separation. | Class II | Cordis Corporation |
| Oct 1, 2021 | OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is... | The device is missing grit blasting on the proximal surface of the femoral stem, which may lead t... | Class II | OmniLife Science |
| Oct 1, 2021 | SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is in... | There is a potential for distal tip dislodgement or separation. | Class II | Cordis Corporation |
| Oct 1, 2021 | Ellume COVID-19 Home Test | Due to a higher rate of false positive test results. | Class I | ELLUME LTD |
| Oct 1, 2021 | SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... | There is a potential for distal tip dislodgement or separation. | Class II | Cordis Corporation |
| Oct 1, 2021 | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
| Oct 1, 2021 | SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is ind... | There is a potential for distal tip dislodgement or separation. | Class II | Cordis Corporation |
| Sep 30, 2021 | API 50 CH, Model 50300 | There is potential to provide an incorrect organism identification. | Class II | bioMerieux, Inc. |
| Sep 30, 2021 | MENTOR Saline-Filled Breast Implants are constructed from room temperature v... | Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch port... | Class II | Mentor Texas, LP. |
| Sep 29, 2021 | LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic... | The firm identified an error in the device temperature monitoring circuitry which is designed to ... | Class II | Covidien Llc |
| Sep 29, 2021 | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF ... | Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... | Class II | Abbott Laboratories |
| Sep 29, 2021 | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/... | Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... | Class II | Abbott Laboratories |
| Sep 29, 2021 | LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W | XXX | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 29, 2021 | Hemodialysis Delivery System, Software Version 2.x. | If the operator initiates therapy with a saved prescription profile and makes a change to the pr... | Class II | Baxter Healthcare Corporation |
| Sep 29, 2021 | Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075 | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coag... | Class II | CooperSurgical, Inc. |
| Sep 28, 2021 | Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G0990... | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below ... | Class II | Cook Inc. |
| Sep 28, 2021 | Atellica IM 1300 Analyzer, SMN 11066001 | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 28, 2021 | Atellica IM 1600 Analyzer, SMN 11066000 | Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 28, 2021 | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143;... | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ... | Class II | ELEKTA SOLUTIONS AB |
| Sep 28, 2021 | Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.... | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below ... | Class II | Cook Inc. |
| Sep 27, 2021 | Cardioblate CryoFlex Surgical Ablation Console | There is potential for intermittent electrical connectivity between the console and probe. | Class II | Medtronic Perfusion Systems |
| Sep 27, 2021 | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of ... | Class II | O&M HALYARD INC |
| Sep 27, 2021 | BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used... | Holes in product packaging impacts package integrity and may compromise sterility. | Class II | Becton Dickinson & Company |
| Sep 24, 2021 | Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) | 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This ... | Class II | Philips Healthcare |
| Sep 24, 2021 | Permobil TiLite, Models: Aero Z, and ZRA | Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor v... | Class II | TiSport, Llc |
| Sep 24, 2021 | Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 i... | Software error, the software can produce an incorrect interpretation of the table rotation if the... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 24, 2021 | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.... | When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) b... | Class II | Philips North America Llc |
| Sep 23, 2021 | Clinician Programmer Application (CPA) model A610 Clinician Software Application | A software anomaly may occur with the clinician programmer application. | Class II | Medtronic Neuromodulation |
| Sep 23, 2021 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 23, 2021 | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01)... | Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is th... | Class II | DiaSorin Molecular LLC |
| Sep 23, 2021 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 22, 2021 | da Vinci SP Surgical systems with the following Model Name/ Model Number / UD... | Issue was identified during internal engineering evaluation. Use of the system with the affected ... | Class II | Intuitive Surgical, Inc. |
| Sep 22, 2021 | VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS SARS-COV-2 IgG, Ref 423834-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Mumps IgG (MPG), REF 30218 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Lyme IgM II (LYM), REF 416436 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS DEX@, Dimer Exclusion II, REF 30455-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations... | An issue where the combined density in a dose grid voxel partially covered by the External ROI an... | Class II | RAYSEARCH LABORATORIES AB |
| Sep 22, 2021 | VIDAS Clostridium Difficile GDH, REF 30125-01 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | VIDAS Measles IgG (MSG), REF 30219 | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate erro... | Class II | bioMerieux, Inc. |
| Sep 22, 2021 | ProxiDiagnost N90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | DigitalDiagnost C90 | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | CombiDiagnost R90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.