Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Oct 10, 2024 Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004... Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... Class I Boston Scientific Corporation
Oct 7, 2024 Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for inva... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invas... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasiv... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B,... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B,... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B,... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 4, 2024 microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended us... A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigatio... Class I FHC, Inc.
Sep 25, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the... Class I Elekta Instrument AB
Sep 25, 2024 Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 118... Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with... Class I Cardinal Health 200, LLC
Sep 20, 2024 VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W... There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. Class I Maquet Cardiovascular, LLC
Sep 16, 2024 Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulm... As a result of product complaints, breathing circuits are experiencing discolored fluid which are... Class I Percussionaire Corporation
Sep 13, 2024 Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Softwar... There is a defect in the air-in-line software algorithm. Class I Zyno Medical LLC
Sep 12, 2024 Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior cart... The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas sourc... Class I Baxter Healthcare Corporation
Sep 3, 2024 GE Heathcare Giraffe OmniBed; neo natal incubator GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Sep 3, 2024 GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo n... GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... Class I DATEX--OHMEDA, INC.
Aug 30, 2024 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9... The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unres... Class I Fresenius Kabi USA, LLC
Aug 30, 2024 Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric em... Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. Class I Mercury Enterprises, Inc. dba Mercury Medical
Aug 22, 2024 KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 00... Potential installation issue that could result in a fire hazard in the event of an interaction be... Class I Kinova Inc
Aug 21, 2024 Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary ... Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... Class I Percussionaire Corporation
Aug 21, 2024 Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Perc... Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... Class I Percussionaire Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 8, 2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.
Aug 7, 2024 Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to... Class I B Braun Medical Inc
Aug 1, 2024 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-... A defect may cause an uncontrolled medication flow condition which may result in a dose greater t... Class I Fresenius Kabi USA, LLC
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 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 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 25, 2024 Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... Class I Breas Medical, Inc.
Jul 24, 2024 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously ... Class I Abbott Diabetes Care, Inc.
Jul 19, 2024 ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ... Thrombectomy system catheter instructions for use updated to reduce adverse events due to the fol... Class I Inari Medical - Oak Canyon
Jul 16, 2024 Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Ev... Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... Class I Philips Respironics, Inc.
Jul 16, 2024 Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Aust... Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... Class I Philips Respironics, Inc.
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.
Jul 16, 2024 Trilogy Evo Universal Ventilator, Model No. DS2000X11B Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... Class I Philips Respironics, Inc.
Jul 12, 2024 Aisys CS2. This anesthesia gas machine is intended to provide general inhalat... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire 100. This anesthesia gas machine is intended to provide general inhal... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 RMU-2000 Automated Chest Compression Device Problem in the device's motor may cause the device to stop compressions. This may lead to a delay... Class I Defibtech, LLC
Jul 12, 2024 Aisys. This anesthesia gas machine is intended to provide general inhalation ... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Aespire View. This anesthesia gas machine is intended to provide general inha... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Amingo. OUS only. Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, Inc.
Jul 12, 2024 Avance. This anesthesia gas machine is intended to provide general inhalation... Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected... Class I Datex-Ohmeda, 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.