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.

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DateProductReasonClassFirm
Feb 14, 2024 STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer repo... Class II Baxter Healthcare Corporation
Feb 14, 2024 HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P... Automated external defibrillators were shipped in their test configuration so there is a potentia... Class II HeartSine Technologies Ltd
Feb 14, 2024 Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods Class II Randox Laboratories Ltd.
Feb 14, 2024 Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30... Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... Class II Covidien, LP
Feb 14, 2024 Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... Class II Covidien, LP
Feb 13, 2024 GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECAR... DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver ... Class I DeRoyal Industries Inc
Feb 12, 2024 Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Boston Scientific has identified a tooling error in manufacturing which may have caused delaminat... Class I Boston Scientific Corporation
Feb 12, 2024 Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument S... There is a galling effect (cold-weld) caused by friction between the array fixation pins and the ... Class II Think Surgical, Inc.
Feb 12, 2024 Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intub... Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... Class II Sarnova HC, Llc
Feb 12, 2024 ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Nu... Teleflex is initiating this voluntary recall for the above-mentioned products due to reports rece... Class I ARROW INTERNATIONAL Inc.
Feb 12, 2024 Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal int... Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... Class II Sarnova HC, Llc
Feb 9, 2024 Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 Due to a manufacturing issue, the screw seat location on the abutment product may be too high, ca... Class II Preat Corp
Feb 8, 2024 microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 11... Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated thi... Class II Landauer
Feb 8, 2024 Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Num... Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may d... Class II EYE COMFORT CARE LLC
Feb 8, 2024 Access Total T4, REF 33800, IVD, thyroxine reagent assay. Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specificati... Class II Beckman Coulter, Inc.
Feb 8, 2024 Chromophare Surgical Light System , REF CH00000001 Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. Class II Stryker Communications
Feb 8, 2024 CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DE... Class II Baxter Healthcare Corporation
Feb 8, 2024 Software VERIQA (S070031), version 2.0 and 2.1- Software package for display,... Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold ... Class II PTW-FREIBURG
Feb 7, 2024 DCA Systems HbA1c Reagent Kit The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a po... Class II Siemens Healthcare Diagnostics, Inc.
Feb 7, 2024 Access Substrate, REF 81906, For use with the Access Immunoassay Systems On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... Class II Beckman Coulter, Inc.
Feb 7, 2024 natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla ... Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol... Class II Natus Neurology Inc
Feb 7, 2024 smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP,... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... Class II Medtronic Perfusion Systems
Feb 7, 2024 smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, RE... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
Feb 7, 2024 TENSIVE Conductive Adhesive Gel, REF 016-401600 Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol... Class II Natus Neurology Inc
Feb 7, 2024 Torrent Suite Dx Software versions 5.14 and earlier used in connection with I... Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems ex... Class II Life Technologies Corporation
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, ... Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 6 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 7 9 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 3 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 Azurion 3 with a Certeray generator -To perform image guidance in diagnostic,... Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 6, 2024 X3 TRIATHLON CS INSERT NO 6 10 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, ... Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 6, 2024 NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Potential packaging breaches of inner blister and outer sterile blister. Class II Howmedica Osteonics Corp.
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 5, 2024 Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Their is a potential that electromagnetic interference may cause leadless pacemaker may result in... Class II Abbott Medical
Feb 5, 2024 EasyPoint Needle, 25G x 5/8", REF: 82091 The needle cannula of a retractable needle may detach from the needle holder in the patient. Class II Retractable Technologies, Inc.
Feb 2, 2024 CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS909... Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractur... Class I Medos International Sarl
Feb 2, 2024 BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... Pack and pouch label is missing the manufacturing and expiration date. Class II Beaver Visitec International, Inc.
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, R... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStatio... Automated dispensing cabinets, running affected software, and Windows 10 operating system may exp... Class II CareFusion 303, Inc.
Jan 31, 2024 Trumpet, Needle Guide, Cat# TMS-200 The Ring on the Trump Needle Guide can detach when excessive pressure is applied. Class II Technicality 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.