Browse Device Recalls
740 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 740 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 740 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2025 | Model Number U226, VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L209 PROPONENT DR (VDD) SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number S702, ALTRUA 2 DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Jul 21, 2025 | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:... | Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16")... | Class I | Tandem Diabetes Care, Inc. |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| Jun 23, 2025 | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... | Class I | Thoratec LLC |
| Jun 18, 2025 | Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator withou... | Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... | Class II | Stryker Corporation |
| Jun 18, 2025 | Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Di... | Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... | Class II | Stryker Corporation |
| Apr 29, 2025 | Azure S DR MRI SureScan, Product number W3DR01 | Identified devices may experience sudden battery power failure without alarm, power supply power-... | Class II | Medtronic, Inc. |
| Mar 24, 2025 | Welch Allyn CP150 Electrocardiograph: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Welch Allyn CONNEX Accessory Power Management Stand: | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 24, 2025 | Welch Allyn Connex Vital Signs Monitor (CVSM): | There were customer reports of devices which experienced battery-related fires. The investigation... | Class II | Baxter Healthcare Corporation |
| Mar 21, 2025 | Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may incre... | Class II | Phasor Health, LLC |
| Mar 6, 2025 | Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number ... | The battery for certain ultrasound systems can potentially develop an internal failure which coul... | Class II | GE Medical Systems, LLC |
| Mar 6, 2025 | Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (... | The battery for certain ultrasound systems can potentially develop an internal failure which coul... | Class II | GE Medical Systems, LLC |
| Mar 5, 2025 | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Due to incorrect the battery charger being packaged and distributed. Product labeling does not m... | Class II | Advanced Bionics, LLC |
| Mar 4, 2025 | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P... | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compre... | Class I | ZOLL Circulation, Inc. |
| Feb 24, 2025 | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibrat... | Class II | PYRAMES INC |
| Feb 15, 2025 | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... | Class II | Abbott Medical |
| Feb 12, 2025 | Mito Red Light, Super Mobile | The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it ... | Class II | MITO RED LIGHT INC |
| Jan 30, 2025 | Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; | Telcare, LLC has received customer complaints related to battery expansion/swelling for its Phili... | Class II | Telcare, LLC |
| Jan 3, 2025 | Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Dec 20, 2024 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 20, 2024 | Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 | There is an issue with the ventilator battery charger that could lead to an audible and visual al... | Class I | Baxter Healthcare Corporation |
| Dec 12, 2024 | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL ... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209),... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Oct 25, 2024 | Galaxy System (GAL-001) | Bronchoscopic system uninterruptable power may have defective component, may cause power supply s... | Class II | Noah Medical |
| Oct 18, 2024 | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. ... | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage... | Class II | Zyno Medical LLC |
| Oct 15, 2024 | OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor t... | Battery movement led to damage of one of the battery cells causing it to short to the battery ret... | Class II | OrganOx Ltd |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | Class II | Caire, Inc. |
| Oct 2, 2024 | RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would be... | Due to issues with battery depletion and inability to recharge if the batteries are not appropria... | Class II | Smith & Nephew Medical, Ltd. |
| Sep 27, 2024 | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a batter... | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal,... | Class II | Accriva Diagnostics, Inc. |
| Sep 23, 2024 | KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),... | The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek s... | Class II | Pro-Dex Inc |
| Sep 4, 2024 | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and b... | The internal power connections at the power inlet of the ultrasound devices can come loose result... | Class II | B-K Medical A/S |
| Jul 31, 2024 | MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1... | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... | Class I | Medtronic MiniMed, Inc. |
| Jul 31, 2024 | MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582,... | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... | Class I | Medtronic MiniMed, Inc. |
| Jul 31, 2024 | MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G I... | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... | Class I | Medtronic MiniMed, Inc. |
| Jul 17, 2024 | Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used wi... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jul 17, 2024 | Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with eith... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jul 16, 2024 | CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also ... | Damage to the battery pack may have caused a short to a capacitor within the battery pack. While... | Class I | Smiths Medical ASD 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.