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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
May 21, 2026 Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520... The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(... Class II Medline Industries, LP
May 15, 2026 Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. ... Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of res... Class I Medline Industries, LP
May 14, 2026 Automated Impella Controller (AIC), for use with left heart support blood pum... Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... Class I Abiomed, Inc.
May 13, 2026 Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Ang... Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have par... Class I Medical Action Industries, Inc. 306
May 13, 2026 Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Ca... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Non-Dedicated Gravity Administration Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Plum administration sets Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star ... Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... Class I AVID Medical, Inc.
Apr 30, 2026 Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722... It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 30, 2026 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 29, 2026 Plum Solo Precision IV Pump, 40001-0401 Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... Class II ICU Medical, Inc.
Apr 29, 2026 Plum Duo Infusion Pump, 40002-0401 Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... Class II ICU Medical, Inc.
Apr 29, 2026 Plum Duo Precision IV Pump, 40002-0403 Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... Class II ICU Medical, Inc.
Apr 24, 2026 EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: ... Blood pump inner package expiration date does not match the outer-correct expiration date, which ... Class II BERLIN HEART GMBH
Apr 24, 2026 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... Class II Intuitive Surgical, Inc.
Apr 21, 2026 Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI ... Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... Class I ARROW INTERNATIONAL, LLC
Apr 21, 2026 Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA ... Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... Class I ARROW INTERNATIONAL, LLC
Mar 27, 2026 Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO Labeling update to provide warning if functionality of the valve replacement delivery system is ... Class II Edwards Lifesciences, LLC
Mar 24, 2026 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, ... Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy de... Class II ICU Medical, Inc.
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Car... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,K... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extrav... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 11, 2026 Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... Class II Medtronic, Inc.
Feb 27, 2026 Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringe... Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FD... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Class II Mentor Texas, LP.

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.