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 |
|---|---|---|---|---|
| Dec 15, 2025 | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 ... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Ki... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, ... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEU... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAK... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, ... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL L... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, K... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Nov 28, 2025 | SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 | Certain pumps have potentially been released from service with defective grease applied to the ca... | Class II | Baxter Healthcare Corporation |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 24, 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... | Software issue only allows Concentration Limits to be defined to one digit of precision past the ... | Class II | ICU Medical, Inc. |
| Nov 24, 2025 | LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Softwar... | For certain customers, the Change Summary review option ceases to operate as expected for any mig... | Class II | ICU Medical, Inc. |
| Nov 21, 2025 | Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,... | Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occur... | Class II | Medline Industries, LP |
| Nov 13, 2025 | FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 13, 2025 | SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 12, 2025 | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co... | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-l... | Class II | Cardinal Health 200, LLC |
| Nov 11, 2025 | DEXLOCK Achilles Repair Implant Kits, MAKT4520 | There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill gu... | Class II | Medline Industries, LP |
| Oct 28, 2025 | Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product... | Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a ... | Class II | Baxter Healthcare Corporation |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number N... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medlin... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Me... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
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.