Browse Device Recalls

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

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DateProductReasonClassFirm
Jul 17, 2025 Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant ... Measles IgM Test Kit lacks premarket approval or clearance. Class II Quest International, Inc.
Jul 17, 2025 SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Fol... Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... Class II C.R. Bard Inc
Jul 17, 2025 SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley ... Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... Class II C.R. Bard Inc
Jul 16, 2025 Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Ti... The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. Wh... Class II Dynex Technologies, Inc.
Jul 16, 2025 TOPS Inserter, part of the TOPS System Instrument Set used for implantation o... Potential for missing pins at tip of inserter. Class II PREMIA SPINE LTD
Jul 16, 2025 Pentax Medical Video Processor; Model Number: EPK-i8020c; During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c serie... Class II Pentax of America Inc
Jul 15, 2025 Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. Inconsistent size terminology and color coding used on labeling Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 15, 2025 Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. Inconsistent size terminology and color coding used on labeling Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 15, 2025 Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade... Surgical lights have stress lines forming on the powder coating, which indicates that powder coat... Class II Stryker Communications
Jul 14, 2025 3mensio Workstation (Vascular Fenestrated) software When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (i... Class II PIE Medical Imaging B.V.
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 Spectrum IQ Infusion Pump, Product Code 3570009 Baxter has identified that certain pumps have potentially been released with the grease applied t... Class II Baxter Healthcare Corporation
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic ... Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 14, 2025 Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) du... Class I Baxter Healthcare Corporation
Jul 14, 2025 Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001... Under certain conditions, such as the simultaneous use of the operating table with other medical ... Class II MAQUET GMBH
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 11, 2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal f... Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... Class II Onkos Surgical, Inc.
Jul 11, 2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAI... Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... Class II Onkos Surgical, Inc.
Jul 11, 2025 Blood/EMB, Levine 100/PK, Product Number R02041 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class II Remel, Inc
Jul 11, 2025 BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U Laryngoscope handles may not illuminate as intended. Class I Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED,... Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... Class II Onkos Surgical, Inc.
Jul 11, 2025 BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1... Laryngoscope handles may not illuminate as intended. Class I Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025 Strep Selective II Agar, Product Number R01859 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class II Remel, Inc
Jul 11, 2025 Blood/MacConkey Biplate 100/PK, Product Number R02049 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class II Remel, Inc
Jul 11, 2025 Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0... Laryngoscope handles may not illuminate as intended. Class I Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025 BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and ... Laryngoscope handles may not illuminate as intended. Class I Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025 BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U Laryngoscope handles may not illuminate as intended. Class I Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025 BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-011... Laryngoscope handles may not illuminate as intended. Class I Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025 Plum Duo Infusion System, List Number: 400020401 ICU Medical identified two sequences of programming events and alarm interactions that may cause ... Class I ICU Medical, Inc.
Jul 11, 2025 Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class II Remel, Inc
Jul 10, 2025 Multi Joystick R-net. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Ca... Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely in... Class II Beckman Coulter, Inc.
Jul 10, 2025 IDM-MULTI-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 All-round Joystick R-net Light. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 IDM-ARLITE-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 Micro Joystick R-net. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 10, 2025 FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nuc... FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures w... Class II Biofire Defense
Jul 10, 2025 Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MI... Reports of delayed access to medication in automated dispensing cabinets because of the override/... Class III CareFusion 303, Inc.
Jul 10, 2025 IDM-MICRO-R. Electrical wheelchair component. Devices with firmware versions 2.3 and lower may experience timing variations between software ta... Class I mo-Vis BVBA
Jul 9, 2025 VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Conditio... Class II Ortho-Clinical Diagnostics, Inc.
Jul 9, 2025 Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us... Label is incorrect. The product label indicates that the device contains an air eliminating filte... Class I B BRAUN MEDICAL INC
Jul 9, 2025 Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, C... Potential for the manometer port being blocked rendering the manometer non-functional. Class I Ambu Inc.
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II Encore Medical, 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.