Browse Device Recalls
1,377 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,377 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 1,377 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jun 12, 2026 | Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS8600... | 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) C-SECTION PREP, Model Number: DYNJ32702B | 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) LABOR CDS, Model Number: CDS981762B; 2) VAG D... | 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) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C | 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) DYKM1414, Catalog Number: DYKM1414; 2) DYKM14... | 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) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYN... | 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 11, 2026 | Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU D... | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... | Class II | Medline Industries, LP |
| Jun 11, 2026 | Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART M... | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... | Class II | Medline Industries, LP |
| Jun 11, 2026 | Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline K... | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... | Class II | Medline Industries, LP |
| Jun 11, 2026 | Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit... | Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... | Class II | Medline Industries, LP |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline ... | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... | Class I | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... | Class II | Medline Industries, LP |
| Jun 8, 2026 | MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Med... | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... | Class I | Medline Industries, LP |
| Jun 5, 2026 | MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU D... | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... | Class I | Medline Industries, LP |
| Jun 5, 2026 | MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835;... | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... | Class I | Medline Industries, LP |
| Jun 5, 2026 | MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... | Class I | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; ... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | 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.