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 |
|---|---|---|---|---|
| Jul 9, 2024 | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jul 9, 2024 | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | IFU update to address device's battery handling information. | Class II | Covidien |
| Jul 9, 2024 | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the deign threshold which... | Class I | Covidien |
| Jun 26, 2024 | smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model... | The adapter input plug can become damaged or broken. If the input plug is damaged, the metal con... | Class II | Smiths Medical ASD, Inc. |
| Jun 20, 2024 | Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireles... | This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and prema... | Class II | Securitas Healthcare LLC |
| Jun 20, 2024 | Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery... | There is a risk that alarms will not be received by the Arial Wireless Emergency Call System and ... | Class II | Securitas Healthcare LLC |
| Jun 4, 2024 | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply... | Class II | Zyno Medical LLC |
| May 29, 2024 | Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life... | Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent c... | Class I | Baxter Healthcare Corporation |
| May 7, 2024 | 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 |
| May 7, 2024 | Plum 360/A+ spare batteries. Item Number: SUB0000864. | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 7, 2024 | Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & ... | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... | Class I | ICU Medical Inc |
| May 1, 2024 | The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-base... | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility b... | Class II | Mermaid Medical A/S |
| Apr 18, 2024 | Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump | Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the... | Class I | OptumHealth Care Solutions LLC |
| Apr 5, 2024 | CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, ... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Apr 5, 2024 | CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001,... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Apr 5, 2024 | CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, ... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| Apr 5, 2024 | CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c)... | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... | Class II | GE Healthcare Finland Oy |
| 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. |
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.