Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 1141–1160 of 38,428 recalls
Recalled Item: Design Options
The Issue: for the lid of the catheter connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Tray
The Issue: for the lid of the catheter connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga.
The Issue: for the lid of the catheter connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERIFIX FX Continuous Epidural Anesthesia Set
The Issue: for the lid of the catheter connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure
The Issue: InSure ONE failed sensitivity testing when used with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System Software Builds 3.1.3
The Issue: When appending a care plan that contains one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent
The Issue: Beckman Coulter has identified that there is an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oral Probe (Product code 02893-000)
The Issue: Affected oral/axillary probes were inadvertently programmed with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400
The Issue: Instructions for use for a foot plating system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phasitron 5
The Issue: IFU update; in-line valve, with pressure relief seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalyft PL & PL40 Expandable Interbody System labeled as follows
The Issue: Expandable interbody system cage may loose height or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)
The Issue: A software anomaly, under specific conditions when large
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number:
The Issue: Due to two distinct issues: 1. During patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Planner
The Issue: A software anomaly, under specific conditions when large
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SuRgical Planner (SRP)
The Issue: A software anomaly, under specific conditions when large
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP)
The Issue: A software anomaly, under specific conditions when large
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)
The Issue: A software anomaly, under specific conditions when large
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Navigation Advanced Platform (SNAP)
The Issue: A software anomaly, under specific conditions when large
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Navigation Advanced Platform Patient Engagement (PE SNAP)
The Issue: A software anomaly, under specific conditions when large
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated Impella Controller (AIC) labeled as the following with corresponding
The Issue: for Automated Impella Controller (AIC) purge pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.