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 |
|---|---|---|---|---|
| Jun 7, 2021 | FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-A... | Due to real-time stability study failures resulting in increase rate of false negative results be... | Class II | BioFire Diagnostics, LLC |
| Jun 7, 2021 | FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 /... | Due to real-time stability study failures resulting in increase rate of false negative results be... | Class II | BioFire Diagnostics, LLC |
| Jun 7, 2021 | Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Gra... | During product complaint investigation, it was determined that during stent graft deployment, the... | Class II | Medtronic Vascular, Inc. |
| Jun 7, 2021 | reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as ... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 7, 2021 | Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent G... | During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of th... | Class II | Medtronic Vascular, Inc. |
| Jun 7, 2021 | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, a... | Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency... | Class II | Pear Therapeutics, Inc. |
| Jun 4, 2021 | SIGNA Voyager, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner des... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner d... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scan... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA MR380, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08... | The patient may be exposed to potential aluminum ion release during warming therapy under certain... | Class I | Eight Medical International BV |
| Jun 4, 2021 | Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 357000... | System errors were noted following changes the customers implemented to the configuration of thei... | Class I | Baxter Healthcare Corporation |
| Jun 4, 2021 | Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance sca... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With ... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | SIGNA Artist, Nuclear Magnetic Resonance Imaging System | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Simpleware ScanIP medical software. For transfer of imaging information from... | A issue (bug) has been identified with the interface and image software which could result in an... | Class II | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| Jun 4, 2021 | SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner des... | GE Healthcare has recently become aware of an issue on the affected products listed below where t... | Class II | GE Healthcare, LLC |
| Jun 4, 2021 | Simpleware ScanIP software. For transfer of imaging information from a medica... | A issue (bug) has been identified with the interface and image software which could result in an... | Class II | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| Jun 3, 2021 | Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f)... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or... | Mislabeled: Labeled on the package as 60mm contains 45mm devices | Class II | Ethicon Endo-Surgery Inc |
| Jun 3, 2021 | VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/1... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF MCS1705PU | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) ... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100US | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/... | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f)... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF 1104JP | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1104 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1103 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) | The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... | Class I | Boston Scientific Corporation |
| Jun 3, 2021 | VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | HeartWare HVAD Pump Accessories, REF MCS1753AK | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bu... | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequ... | Class II | Axonics Modulation Technologies, Inc. |
| Jun 3, 2021 | HeartWare HVAD Outflow Graft, REF MCS1725OG | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1153 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1125 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 2, 2021 | ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administrati... | Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 2, 2021 | Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM ... | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... | Class II | Biomet, 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.