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 |
|---|---|---|---|---|
| Sep 25, 2023 | Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-5936... | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles... | Class II | Securitas Healthcare LLC |
| Sep 25, 2023 | Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; ... | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles... | Class II | Securitas Healthcare LLC |
| Sep 25, 2023 | Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59... | Premature battery depletion presents a risk that alarms will not be received by the Arial Wireles... | Class II | Securitas Healthcare LLC |
| Sep 21, 2023 | 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ... | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... | Class I | B. Braun Medical, Inc. |
| Sep 13, 2023 | Astral 100 and Astral 150 ventilators | If ventilator is on internal battery, not intended to serve as a primary power source, low/critic... | Class I | ResMed Ltd. |
| Aug 16, 2023 | Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDH... | Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... | Class II | Abbott Medical |
| Aug 16, 2023 | Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gal... | Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... | Class II | Abbott Medical |
| Aug 10, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software update corrected an issue where "low" and "terminal" battery alerts did not display on... | Class II | Turncare, Inc |
| Jul 31, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting that the device was not charging as expected. It was discovered that users w... | Class I | Datascope Corp. |
| Jul 31, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... | Users were reporting that the device was not charging as expected. It was discovered that users w... | Class I | Datascope Corp. |
| Jul 21, 2023 | Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live i... | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-... | Class II | Ambu Inc. |
| Jul 18, 2023 | Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: Th... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Pro... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Pro... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 18, 2023 | Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The ... | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging... | Class I | Abbott Medical |
| Jul 13, 2023 | Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and... | May have a battery life lasting less than the full 48 hours, requiring the device to be charged m... | Class II | EMPATICA SRL |
| Jul 6, 2023 | SofTech Pressure-Sensing Wheelchair Cushions | Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p... | Class II | Aquila Corporation |
| Jul 6, 2023 | APK2 Pressure-Sensing Wheelchair Cushions | Defective battery pack in wheelchair cushions can overheat resulting in property damage and one p... | Class II | Aquila Corporation |
| Jun 19, 2023 | GEM FLOW COUPLER Monitor, PN 5156-00000-011 | An issue was identified where the LCD monitor display may not indicate the correct active channel... | Class II | Baxter Healthcare Corporation |
| Jun 12, 2023 | Oxylog 3000 Plus emergency and transport ventilator | Draeger has become aware of instances where the device stopped working when in use when transitio... | Class I | Draeger Medical, Inc. |
| Jun 5, 2023 | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... | IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... | Class I | Datascope Corp. |
| Jun 5, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... | IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... | Class I | Datascope Corp. |
| Apr 26, 2023 | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separate... | Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cel... | Class II | HeartSine Technologies Ltd |
| Mar 22, 2023 | Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusi... | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| Mar 22, 2023 | ASM Replacement Battery, Component Number SUB0000594 | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| Mar 22, 2023 | ASM Replacement Battery, Component Number SUB0000864 | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| Mar 22, 2023 | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| Feb 24, 2023 | Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device us... | Problem maintaining the stable placement of the battery may come loose from the housing and beco... | Class II | Tobii Dynavox Llc |
| Feb 20, 2023 | Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-ter... | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolong... | Class II | Moberg Research, Inc. |
| Feb 15, 2023 | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), u... | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-... | Class II | Pro-Dex Inc |
| Nov 18, 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to ... | Class II | Mobius Imaging, LLC |
| Nov 7, 2022 | Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Pr... | The power backup battery, under certain conditions, may exhibit reduced battery run-time while in... | Class II | Getinge Usa Sales Inc |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IP... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN00... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-040... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF I... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL Inc. |
| Oct 17, 2022 | Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN... | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump... | Class I | ARROW INTERNATIONAL 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.