Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence... | Class II | Luminex Molecular Diagnostics Inc |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use... | IFUs for the device incorrectly states the biotin interference was remediated. The issue could r... | Class II | Beckman Coulter, Inc. |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) CONE BIOP... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure conve... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) OB PACK-L... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) KIT LINE ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) NEURO PAC... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-L... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) SET UP PAC... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOG... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure conve... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESI... | XXX | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 140470... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure conven... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and b... | The internal power connections at the power inlet of the ultrasound devices can come loose result... | Class II | B-K Medical A/S |
| Sep 4, 2024 | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable de... | Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may pre... | Class II | Howmedica Osteonics Corp. |
| Sep 4, 2024 | Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDU... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDO... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, f... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | The EVSRF catheter is a sterile, single-use disposable medical device for end... | The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The r... | Class II | Bard Peripheral Vascular Inc |
| Sep 4, 2024 | Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure conven... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) PLASTIC P... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | 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.