Browse Device Recalls

2,910 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,910 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 2,910 FDA device recalls in IL.

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DateProductReasonClassFirm
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
May 30, 2025 Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mo... The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... Class I Baxter Healthcare Corporation
May 30, 2025 Hillrom LikoScale component, Product Code 3156232, used with the following a... The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... Class I Baxter Healthcare Corporation
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2025 Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile pr... Class II MEDLINE INDUSTRIES, LP - Northfield
May 13, 2025 Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Ken... Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... Class II Cardinal Health 200, LLC
May 13, 2025 Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendal... Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... Class II Cardinal Health 200, LLC
May 13, 2025 SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves w... Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause del... Class II Cardinal Health 200, LLC
May 12, 2025 Baxter Novum IQ Syringe Pump, product code 40800BAXUS, Baxter has identified a design issue which may cause the pump to detect the presence of a syringe... Class II Baxter Healthcare Corporation
May 9, 2025 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope ... The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the... Class II Baxter Healthcare Corporation
May 8, 2025 GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will g... Class II Ohio Medical Corporation
May 6, 2025 Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E1004... There is a potential for improper crimps on the signal wires of the actuators which could result ... Class II Baxter Healthcare Corporation
May 2, 2025 Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... Firm has identified Drug Library Management defects in the software: 1) DLM software does not all... Class II ICU Medical, Inc.
May 2, 2025 Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
May 2, 2025 Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and... Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... Class II Cardinal Health 200, LLC
Apr 28, 2025 Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a ... There were reports of an increase in reactive negative controls and false positive results. Class II Abbott Molecular, Inc.
Apr 28, 2025 Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time r... There were reports of an increase in reactive negative controls and false positive results. Class II Abbott Molecular, Inc.
Apr 24, 2025 Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of... Class I Baxter Healthcare Corporation
Apr 22, 2025 ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400... Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... Class II ICU Medical, Inc.
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACC... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2025 ICU Medical Plum Solos, Item number 400011001; infusion pump Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... Class II ICU Medical, Inc.
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SK... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 16, 2025 VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-02... It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negati... Class II Luminex Corporation
Apr 10, 2025 Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... Class I Vyaire Medical
Apr 10, 2025 Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... Class I Vyaire Medical
Apr 9, 2025 Centurion Sterile Weitlaner Retractor, Reorder: 67315 Three is the potential for the retractors to puncture through the sterile packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 9, 2025 Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 Three is the potential for the retractors to puncture through the sterile packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 7, 2025 Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2... A cybersecurity vulnerability was discovered through internal testing. Class I Baxter Healthcare Corporation
Apr 7, 2025 Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-... A cybersecurity vulnerability was discovered through internal testing. Class I Baxter Healthcare Corporation
Mar 24, 2025 Welch Allyn CP150 Electrocardiograph: There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 24, 2025 Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 7... A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline ... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 24, 2025 Welch Allyn CONNEX Accessory Power Management Stand: There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 24, 2025 Welch Allyn Connex Vital Signs Monitor (CVSM): There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 8... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff ... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Pr... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 20, 2025 The Alinity m System is designed to automate the steps for nucleic acid testi... The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or s... Class II Abbott Molecular, Inc.
Mar 19, 2025 Medline procedure kits, labeled as: HAND, REF DYNJ902002J It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 19, 2025 Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles w... Class II MEDLINE INDUSTRIES, LP - Northfield

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.