Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 8, 2021 | BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usa... | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators a... | Class II | BIOTRONIK Inc |
| Mar 5, 2021 | Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cuttin... | Investigations related to customer complaints received for particulate matter inside of the Surgi... | Class II | Covidien |
| Mar 2, 2021 | Consist of a distal connection mechanism (either standard Terumo Ball Quick C... | There is a potential for the stainless steel locking plates on the device's sternal retractor loc... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 1, 2021 | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0... | Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software U... | Class II | Abiomed, Inc. |
| Feb 26, 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... | Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regard... | Class I | Heartware, Inc. |
| Feb 25, 2021 | Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the col... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 25, 2021 | Amicus Exchange Kit - Product Usage: intended for use in the collection of bl... | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during ... | Class II | Fenwal Inc |
| Feb 22, 2021 | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for s... | There is a potential presence of particulate matter in the D-Vial. | Class II | Sirtex Medical Limited |
| Feb 22, 2021 | The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Produc... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 22, 2021 | The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consist... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 22, 2021 | ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually package... | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to ... | Class II | DePuy Orthopaedics, Inc. |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 21, 2021 | Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referr... | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does... | Class II | G & H Wire Company |
| Jan 7, 2021 | Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, La... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, La... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG,... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab ... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat,... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab C... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, L... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, L... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Heal... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, ... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Jan 7, 2021 | Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab... | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... | Class II | Cardinal Health 200, LLC |
| Dec 17, 2020 | EXOGEN Ultrasound Coupling Gel | Product may contain white particulates that are microbial in nature. | Class II | Bioventus, LLC |
| Dec 16, 2020 | REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE ... | Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... | Class II | Medtronic Neurosurgery |
| Dec 16, 2020 | REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE ... | Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... | Class II | Medtronic Neurosurgery |
| Dec 16, 2020 | REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE ... | Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the de... | Class II | Medtronic Neurosurgery |
| Dec 14, 2020 | Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use... | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... | Class II | Integra LifeSciences Corp. |
| Dec 14, 2020 | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: u... | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled ... | Class II | Integra LifeSciences Corp. |
| Dec 11, 2020 | FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... | The software does not update measurements and calculations in the Clinical Reporting Application ... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Dec 2, 2020 | 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Produ... | Due to the incorrect filter assembly. | Class II | ICU Medical, Inc. |
| Dec 2, 2020 | 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Produc... | Due to the incorrect filter assembly. | Class II | ICU Medical, Inc. |
| Dec 2, 2020 | 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage:... | Due to the incorrect filter assembly. | Class II | ICU Medical, Inc. |
| Dec 2, 2020 | 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron F... | Due to the incorrect filter assembly. | Class II | ICU Medical, Inc. |
| Nov 9, 2020 | icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended fo... | Due to a potential software issue, the display may show the incorrect continuous cardiac output (... | Class II | ICU Medical, Inc. |
| Oct 23, 2020 | Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usag... | The distal tip ring of the fully articulating catheter may become dislodged during the procedure. | Class II | Intuitive Surgical, Inc. |
| Oct 19, 2020 | Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral fo... | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... | Class II | Geistlich Pharma North America, Inc. |
| Oct 19, 2020 | Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for... | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... | Class II | Geistlich Pharma North America, Inc. |
| Oct 19, 2020 | Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for fi... | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and t... | Class II | Geistlich Pharma North America, Inc. |
| Oct 16, 2020 | Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat... | In-house lab observations and customer reports of overheating and/or thermal damage to the batter... | Class II | Covidien Llc |
| Sep 24, 2020 | AMS 700 MS Pump with and without InhibiZone, sold as individual units and als... | The recalling firm has observed an increase in complaints of problems encountered during the init... | Class II | Boston Scientific Corporation |
| Sep 22, 2020 | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038... | When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated se... | Class I | Flexicare Medical Ltd. |
| Sep 17, 2020 | Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage... | A potentially shorter than specified nebulizer connector may result in difficulty in installing t... | Class II | Getinge Group Logistics America, LLC |
| Sep 11, 2020 | Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Produc... | The magnet located inside the foot pedal may come off and may result in unattended start of unsto... | Class II | Bien-Air Surgery Sa |
| Sep 8, 2020 | MediCult Vitrification Cooling Media, Model Number 12284001F | There is a discrepancy between the printing on the Product Tyvek label of the individual componen... | Class II | CooperSurgical, Inc. |
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.