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 18741–18760 of 38,428 recalls
Recalled Item: Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP)
The Issue: The heated tube sets were consistently leaking and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity ci-series System Control Module software version 2.5.1
The Issue: performance issues in the Alinity-ci software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer
The Issue: There were multiple issues identified in the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica Sample Handler Prime
The Issue: There were multiple issues identified in the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer
The Issue: There were multiple issues identified in the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray BCID Panel
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Blood Collection Assembly with Male Luer Lock
The Issue: The luer could break and cause the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruDi NAV Suction
The Issue: The firm became aware that three (3) lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruDi NAV Suction
The Issue: The firm became aware that three (3) lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruDi NAV Suction
The Issue: The firm became aware that three (3) lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Gastrointestinal (GI) Panel
The Issue: Elevated rates of false positive results for Campylobacter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a
The Issue: When a patient is selected in the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaBeam Handpiece
The Issue: Certain lots may develop an internal leak due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled...
The Issue: Based on internal investigations, Fresenius Kabi has identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
The Issue: The firm has initiated a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
The Issue: The firm has initiated a recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 -
The Issue: The firm issued an updated instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRIdian Linac Radiation Therapy System Model 10000 and 20000
The Issue: Issue with transferring treatment regiment from one system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System
The Issue: Leak from the septum assembly or the canister
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec HeartMate 3 Coring Tool
The Issue: Small black plastic particle was observed in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.