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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.