Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

Clear
DateProductReasonClassFirm
Jan 24, 2024 RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adult... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicl... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & acc... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation ... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 impression coping, repositionable, short, screw-retained, PF 4.0 The depth of the internal canal was not manufactured according to specifications. Thus, the impre... Class II Thommen Medical AG
Jan 24, 2024 Atellica IM Erythropoietin (EPO) Assay (100 Test) Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd... Class II Siemens Healthcare Diagnostics, Inc.
Jan 24, 2024 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing frac... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenera... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 23, 2024 CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate packa... Product failed sterility testing. Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 23, 2024 stay-safe /Safe Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Luer Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Luer Catheter Ext. 6 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Luer Lock Catheter Ext. 18 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Luer Lock Adapter 4 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 i... Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. Class II Parker Laboratories, Inc.
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 VITROS 3600 Immunodiagnostic System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... Class II Ortho-Clinical Diagnostics, Inc.
Jan 22, 2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. S... Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter ... Class II B. Braun Medical, Inc.
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection ... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 VITROS XT7600 Integrated System Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... Class II Ortho-Clinical Diagnostics, Inc.
Jan 22, 2024 Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model... Potential interference with the anti-fall system. Class II SEDECAL SA
Jan 22, 2024 VITROS 5600 Integrated System (New and Refurbished) Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VI... Class II Ortho-Clinical Diagnostics, Inc.
Jan 22, 2024 Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component... Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to pre... Class II Invacare Corporation
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Loc... Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter... Class II B. Braun Medical, Inc.
Jan 22, 2024 LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- In... Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it shoul... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 19, 2024 Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachno... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-bas... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit ... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space o... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-base... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access t... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid ... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catal... Devices without transmural drainage holes may be mislabeled as devices with transmural drainage h... Class II W.L. Gore & Associates, Inc.
Jan 19, 2024 Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-base... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 19, 2024 Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and... A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required pac... Class II Integra LifeSciences Corp.
Jan 17, 2024 ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 4169... The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for... Class II ConvaTec, Inc
Jan 16, 2024 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: ... MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... Class I Avanos Medical, Inc.
Jan 16, 2024 W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Mo... 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. Th... Class II W&H DENTALWERK BUERMOOS GMBH

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.