Browse Device Recalls
788 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 788 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 788 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 24, 2021 | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluorosco... | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of th... | Class II | Philips North America Llc |
| Oct 28, 2021 | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 RE... | Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a ... | Class II | Osteomed, LLC |
| Oct 21, 2021 | ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... | If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... | Class II | Philips North America Llc |
| Oct 21, 2021 | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numb... | If the system experiences an overvoltage / power surge it can cause a short circuit condition wit... | Class II | Philips North America Llc |
| 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 |
| Aug 19, 2021 | P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 | The rear heater plate and cover assembly that contains the electrical wiring for the heaters does... | Class II | Fort Defiance Industries, LLC |
| Aug 11, 2021 | SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for us... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indica... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for u... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated f... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical ... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Aug 11, 2021 | Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for... | When using manual mode, the tabletop may not completely move in or out and result in potential de... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for u... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicate... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use ... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jul 30, 2021 | Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for... | Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may re... | Class II | Philips North America Llc |
| Jun 23, 2021 | Covidien Sonicision Reusable Generator-converts electrical power from the bat... | Potential for a manufacturing assembly error-may result in a non-functional audio indicator of de... | Class II | Covidien Llc |
| Jun 9, 2021 | Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, me... | Expired adhesive used as an electrical insulation barrier and as a secondary retention bond faile... | Class II | Olympus Corporation of the Americas |
| 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 | 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 | 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 | 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 | 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 | 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 1, 2021 | Medtronic Reveal LINQ LNQ11 / PA96000 | Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 22, 2021 | ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount m... | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... | Class II | Welch Allyn Inc |
| Apr 22, 2021 | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall ... | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electric... | Class II | Welch Allyn Inc |
| Mar 3, 2021 | Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers... | An electrical component within the system controller module of certain Bio-Console 560 devices ma... | Class I | Medtronic Perfusion Systems |
| Jan 29, 2021 | S-Series Equipment Management System; Model Number(s):0682400550; UDI: 076133... | The manufacturer has become aware that there is a likelihood that the S-Series Equipment Manageme... | Class II | Stryker Communications |
| Dec 21, 2020 | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No.... | Medical device non-conformance to electrical safety standard (IEC 60601-1). | Class II | Nihon Kohden America Inc |
| Dec 11, 2020 | Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended f... | The electrical contactor component present in the drying chamber of the Reliance Vision Single-Ch... | Class II | Steris Corporation |
| Dec 2, 2020 | EMBLEM MRI S-ICD Model A219 | Electrical overstress may lead to device malfunction. | Class I | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM S-ICD Model A209 | Electrical overstress may lead to device malfunction. | Class I | Boston Scientific Corporation |
| Sep 14, 2020 | Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Mode... | The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator... | Class II | Philips North America, LLC |
| Sep 14, 2020 | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model ... | The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator... | Class II | Philips North America, LLC |
| Sep 11, 2020 | Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: i... | 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 11, 2020 | Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product U... | 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 11, 2020 | Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Pr... | 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 | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
| Sep 8, 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
| Sep 8, 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... | Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. | Class II | GE Healthcare, LLC |
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.