Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
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
Sep 20, 2023 Monoject" 60 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 20 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 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 14, 2023 Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica... GE HealthCare has become aware of an issue where images from two different patients may be contai... Class II GE Healthcare
Sep 14, 2023 Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Rad... GE HealthCare has become aware of an issue where images from two different patients may be contai... Class II GE Healthcare
Sep 14, 2023 Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW found... GE HealthCare has become aware of an issue where images from two different patients may be contai... Class II GE Healthcare
Sep 13, 2023 Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Pr... Syringe contains conical tip that is not compatible with certain needleless IV connector(s). Class II Cardinal Health 200, LLC
Sep 8, 2023 Centricity Universal Viewer Workflow Manager, Image processing radiological s... When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... Class II GE Healthcare
Sep 8, 2023 Universal Viewer Workflow Manager, Image processing radiological system When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... Class II GE Healthcare
Aug 16, 2023 Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Fr... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Steri... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexne... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MH... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) ... XXX Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced S... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II 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.