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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.