Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
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 II TO AVVIGO... 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 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 + 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 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 II TO AVVIGO... 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 II TO AVVIGO... 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 NxTAG Respiratory Pathogen Panel, REF: I051C0447 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 + 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+ BRIDGE TO I... 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 II TO AVVIGO... 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 II TO AVVIGO... 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 + 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 II TO AVVIGO... 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 II TO AVVIGO... Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... Class II Boston Scientific Corporation
Sep 5, 2024 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,... May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from e... Class II Stryker Corporation
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) 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 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: 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: 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) 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) 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 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) 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 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 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 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 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 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 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 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 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 Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U There was an increase in complaints indicating an occurrence of system error E1226 "Could not wri... Class II Olympus Corporation of the Americas
Sep 4, 2024 Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227... 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: a) LITHOTOMY... 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) 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 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 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 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 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 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

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.