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 10601–10620 of 38,428 recalls
Recalled Item: TEG 5000 Functional Fibrinogen Reagent
The Issue: Due to a shift in the citrated blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Wet -Field Eraser
The Issue: Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-Line ventilator adaptor
The Issue: There is a potential of reduced oxygenation or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-Line ventilator adaptor
The Issue: There is a potential of reduced oxygenation or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control
The Issue: Software issue, resuming an interrupted treatment will result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control
The Issue: Software issue, resuming an interrupted treatment will result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Back up batteries in Avance CS2 and Avance CS2 Pro
The Issue: Backup batteries can fail earlier than their estimated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Field replacement back up batteries distributed on or after April 1
The Issue: Backup batteries can fail earlier than their estimated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioTek EP-TRACER Software V2.x.
The Issue: Device did not pass electrical safety testing for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: Start-up time for the flow rate range greater
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: Downstream occlusion alarm is sometimes immediately followed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper
The Issue: Part (A-rubber) intended for a different model of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonovideoscope Model CF-H180AL
The Issue: A (Camera unit) CCD intended for a different
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is the potential that a 6 Fr
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reliance Synergy Washer/Disinfector
The Issue: The firm identified that when the electrical contactor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market
The Issue: Firm received 10 complaints of skin barrier delamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Suture Kit
The Issue: There is uncertainty about the integrity of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5
The Issue: Right nails were anodized, marked, and labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0
The Issue: Due to interference with the Live Listen feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation
The Issue: Mismatch between the expiration date on the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.