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 |
|---|---|---|---|---|
| Aug 14, 2026 | Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand P... | Potential fire hazard involving the hand control pendant and associated wiring used with affected... | Class I | Medline Industries, LP |
| Aug 14, 2026 | Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR1... | Potential fire hazard involving the hand control pendant and associated wiring used with affected... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DY... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) AC... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYND... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; ... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYND... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number:... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; ... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. ... | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; ... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. SI... | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits CATARACT PACK DYNJ59881A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 23, 2026 | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N | The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for... | 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 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 |
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.