Browse Device Recalls

3,306 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,306 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 3,306 FDA device recalls in IL.

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DateProductReasonClassFirm
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 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 7, 2023 Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cul... Potentially defective utility trays in the reagent kits. Class II Luminex Corporation
Nov 3, 2023 PVP SOLUTION SING STRL, REF DYNDA1858 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP SLN KIT, REF DYNDM1097 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE STERILE PREP STICK, REF DYNDA1134 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP, REF DYNDA1649 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE BETADINE, REF DYNDA1998 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE POVIDONE, REF DYNDA2061 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 3, 2023 STERILE PVP SOLUTION, REF DYNDA1907 The product description on the labeling includes the word "Sterile" or STRL", however the content... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 24 BLOOD CULTURE KIT, REF DYNDH1632 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 BLOOD CULTURE KIT, REF DYNDH1647B This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2023 ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 This recall is being issued due to items within the kit have expired prior to the overall kit exp... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 30, 2023 Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. Th... Abbott has received reports of an increase in reactive negative controls and false positive resul... Class II Abbott Molecular, Inc.
Oct 27, 2023 vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used wi... Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator... Class II Vyaire Medical
Oct 27, 2023 vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used wi... Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator... Class II Vyaire Medical
Oct 23, 2023 stryker Sage PrimaFit External Urine Management System for the Female Anatomy A small percentage of devices in three lots of product may contain a tape with a natural rubber l... Class II Sage Products Inc
Oct 19, 2023 Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY... The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... Class II Abbott Laboratories
Oct 19, 2023 Medline Leg bag, REF DYND12578 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023 Medline Leg bag, REF DYND12574 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 19, 2023 Medline Leg bag, REF URO12573 Undeclared latex Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Train... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023 Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with ... The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 13, 2023 Novum IQ Syringe infusion system, Product Code 40800BAXUS Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter ident... Class I Baxter Healthcare Corporation
Oct 4, 2023 HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000... Progressa+ beds have the potential for static buildup from the casters and/or power drive. This s... Class II Baxter Healthcare Corporation
Oct 2, 2023 Coapt ControlSeal Electrode, cutaneous EMG Electrode Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa... Class II Coapt LLC
Oct 2, 2023 Coapt Dome Electrode, Gen2 system, cutaneous electrode Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa... Class II Coapt LLC
Sep 20, 2023 Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC

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.