Browse Device Recalls
812 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 812 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 812 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-4016... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pac... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1) AN... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | See RES Description | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS9... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number C... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | see RES for description | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS84... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Num... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1)... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pa... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pa... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1)... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Num... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Nu... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CD... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Num... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack N... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number D... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, P... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DY... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT67... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: SCS-LF, DYNJ902314D | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Numb... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CD... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU,... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTH... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Nu... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Numbe... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS9802... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Num... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYK... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | 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.