Browse Device Recalls

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Apr 27, 2026 Aligned Medical AMS16835 Fluids Kit RX Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was ... Class II Windstone Medical Packaging, Inc.
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 3, 2026 Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
Apr 2, 2026 Custom Convenience Kit containing recalled Medline Namic Angiographic Control... Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to ... Class I Windstone Medical Packaging, Inc.
Mar 11, 2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... Class II Windstone Medical Packaging, Inc.
Mar 11, 2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... Class II Windstone Medical Packaging, Inc.
Mar 11, 2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... Class II Windstone Medical Packaging, Inc.
Feb 27, 2026 Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1... The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Sy... Class II Cardinal Health 200, LLC
Feb 18, 2026 Sterile Radiology Procedure Kits, Model Number DYNDH1491B There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which m... Class II Medline Industries, LP
Feb 10, 2026 Artegraft Vascular Graft; REF#: AG740; Labeling mix-up resulting in the incorrect lot outer packaging of product. Class II LeMaitre Vascular, Inc.
Feb 10, 2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... Class II Boston Scientific Corporation
Jan 27, 2026 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bu... During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch d... Class II Becton Dickinson & Company
Jan 16, 2026 MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1)... Potential packaging failures, which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026 Private Label CVS. Model Number: CVS405406. Helps maintain a moist woun... Potential packaging failures, which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026 MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 3180... Potential packaging failures, which could lead to a breach in the sterile barrier. Class II Integra LifeSciences Corp. (NeuroSciences)
Jan 7, 2026 Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Num... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See complete list in RES, exceeds character limit. Medline Surgical Gowns Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CD... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2)... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAM... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: C... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYK... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GL... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP24... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA;... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2)... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE14... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) C... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, 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.