Browse Device Recalls

1,490 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,490 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 1,490 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 13, 2026 Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO... Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... Class II Medline Industries, LP
Jul 13, 2026 Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product ... Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... Class II Medline Industries, LP
Jul 13, 2026 Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NE... Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; ... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SK... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU C... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU C... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU ... Component labeling discrepancy Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DY... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU C... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline K... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 10, 2026 Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS98... Kits contain a potentially contaminated component which were recalled by the manufacturer Class II Medline Industries, LP
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline ... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SK... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jul 8, 2026 Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Ki... Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... Class II Medline Industries, LP
Jun 30, 2026 Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 cou... Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... Class II Medline Industries, LP
Jun 30, 2026 Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Produc... Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... Class II Medline Industries, LP
Jun 30, 2026 Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Prod... Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... Class II Medline Industries, LP
Jun 30, 2026 Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, ... Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... Class II Medline Industries, LP
Jun 29, 2026 American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: T... The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 29, 2026 American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 29, 2026 American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 29, 2026 American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: L... The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 12, 2026 Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2)... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; ... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC0... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CD... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) P... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, ... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... 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.