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 29121–29140 of 38,428 recalls
Recalled Item: ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit...
The Issue: Possibility that the catheter peel-away component hub tabs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco - Radiation Treatment Planning used to make treatment plans
The Issue: Unintended update of Dose and MU and Incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number:
The Issue: Complaint investigation concluded that although product quality requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DR Systems Unity PACS software
The Issue: The software fails to associate to the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm
The Issue: Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYDRO-TEMP(R) Neonatal Temperature Skin Sensor
The Issue: DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator
The Issue: The following MRx software issue has been identified:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm)
The Issue: Incorrectly packaged with a 90 degree bend at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome" Chronic Catheter Kit Symmetrical Tip
The Issue: Incorrectly packaged with a 90 degree bend at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision Chronic Catheter Kit Symmetrical Tip
The Issue: Incorrectly packaged with a 90 degree bend at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision Chronic Catheter Kit Symmetrical Tip
The Issue: Incorrectly packaged with a 90 degree bend at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision Chronic Catheter Kit Symmetrical Tip
The Issue: Incorrectly packaged with a 90 degree bend at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Taut Intraducers 10/BX7.5 FR 3.5
The Issue: The defective component can cause gas leakage through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SilverStat
The Issue: During a review of the IFU of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neptune Plus
The Issue: The IFU of the Neptune Plus Pads, does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SSS Reprocessed Zimmer
The Issue: It was reported that packaging was not properly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Two-stage and three-stage I.V. poles are shipped as an optional
The Issue: It was identified by a customer complaint that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspiration Ventilator System
The Issue: A component on the systems power board can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access CEA Assay
The Issue: Beckman Coulter is recalling the Access CEA reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovoCut Suture Manager
The Issue: The NovoCut Suture Manager device may cut the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.