Browse Device Recalls
723 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 723 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 723 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 5, 2024 | CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / ... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Mar 20, 2024 | Dr¿ger Perseus A500 Anesthesia Workstation | Unexpected shutdown while operating on battery power. | Class I | Draeger Medical, Inc. |
| Mar 19, 2024 | Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatr... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ve... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 5, 2024 | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Co... | During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iO... | Class I | Tandem Diabetes Care, Inc. |
| Mar 1, 2024 | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | There is a potential that the Cholestech LDX battery (an external battery pack available as an op... | Class II | Alere San Diego, Inc. |
| Feb 21, 2024 | Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Feb 21, 2024 | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulat... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Jan 24, 2024 | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing frac... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 22, 2024 | Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model... | Potential interference with the anti-fall system. | Class II | SEDECAL SA |
| Dec 26, 2023 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to ... | Class II | Ossur H / F |
| Dec 19, 2023 | smiths medical Medfusion Model 4000 syringe pump | Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the f... | Class I | Smiths Medical ASD Inc. |
| Dec 7, 2023 | Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num... | During internal review of Polaris battery assembly data from the HiPot operation, a test systems ... | Class II | Medtronic Inc. |
| Dec 5, 2023 | Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 | Instructions for Use have been updated to add the following warning: Use only M4 screws with the ... | Class II | Ambu Inc. |
| Nov 17, 2023 | Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atla... | Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains... | Class II | Draegerwerk Ag & Co. Kgaa |
| Nov 1, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software issue where "low" and "terminal" battery alerts did not display on the screen to the u... | Class II | Turncare, Inc |
| Oct 2, 2023 | Coapt ControlSeal Electrode, cutaneous EMG Electrode | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa... | Class II | Coapt LLC |
| Oct 2, 2023 | Coapt Dome Electrode, Gen2 system, cutaneous electrode | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa... | Class II | Coapt LLC |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| 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 |
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.