Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

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DateProductReasonClassFirm
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF V... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test o... Class II Baxter Healthcare Corporation
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 The INFX-8000F is designed to take advantage of the latest technological inno... VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... Class II Canon Medical System, USA, INC.
Nov 15, 2023 SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. New User Manual with additional instructions for use and a hose and mask adapter provided by the ... Class II SoClean, Inc
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, RE... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CD... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, R... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, RE... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, R... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS9... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-... MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two po... Class II Landauer
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CD... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT,... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY -... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511 Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 14, 2023 CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide ... CARDIOHELP-i System was not properly tested to measure leakage current Class III Maquet Medical Systems USA
Nov 14, 2023 BD Recanalization System, REF: BDRECANSYSTEM Recanalization systems may be in a manufacturing mode that allows the system to continuously run ... Class II Bard Peripheral Vascular Inc
Nov 13, 2023 Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level... There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum ... Class II Randox Laboratories Ltd.
Nov 13, 2023 Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pa... Identification label on affected hookups could become illegible over time due to the label's ink ... Class II Steris Corporation
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-40, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 13, 2023 Medtronic SynchroMed II, Model 8637-20, Programmable pump Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... Class II Medtronic Neuromodulation
Nov 13, 2023 Venous probe connection cable (REF 701069333 and 701048804) used with the Car... Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe con... Class II Maquet Medical Systems USA
Nov 13, 2023 CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Possibility that the user is unable to resolve drill disconnection error messages. Class II Blue Belt Technologies, Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 Medex LOGICAL CATH LAB KIT, List Number M20754 There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 6IN PRESSURE TUBING, List Number MX20617 There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilati... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation o... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... Due to incorrect product/device within packaging. Class II Encore Medical, LP
Nov 10, 2023 EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of ... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of st... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation... Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting a... Class II Olympus Corporation of the Americas
Nov 10, 2023 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd Inc
Nov 10, 2023 Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R There is a manufacturing defect affecting specific rotator lots. Within this population, the inne... Class II Smiths Medical Asd 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.