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 26761–26780 of 38,428 recalls
Recalled Item: The Better-Bladder With 14" ID tubing
The Issue: Twisted or wrinkled balloon components which are considered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Bigger-Better-Bladder
The Issue: The seal between the balloon and the housing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fluorocell PLT reagent
The Issue: There is a potential that fluorescent platelet (PLT-F)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 120 V Neptune 3 Rover
The Issue: Stryker initiated a voluntary recall of the 120
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The
The Issue: Nidek Inc. received information from our manufacturer NIDEK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a
The Issue: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 91496 Ultraview SL Command Module
The Issue: The firm has received multiple reports of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mentor MemoryGel Breast Implant
The Issue: The box of 300cc MemoryGel Breast Implant was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIAMOND-FLEX CIRCULAR RETRACTOR
The Issue: BD, formerly CareFusion, has identified a potential risk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7
The Issue: There is an observed failure of the backrest
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra External Fixation System Rocker Bottom Model # 12225400. For
The Issue: The silicone insert embedded in the rocker bottom
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 3.0
The Issue: An issue was found with the evaluation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System
The Issue: Stryker discovered that a Tibial Nail and femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Nail
The Issue: Stryker discovered that a Tibial Nail and femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System
The Issue: Vision RT Ltd received three (3) reports from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is
The Issue: Vision RT Ltd received three (3) reports from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROFEMUR(R) MODULAR NECK
The Issue: Profemur(R) neck, Item Number PHA01222 (Short AR VV2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled...
The Issue: Zimmer Bioment Spine, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medivance ArcticGel Neonatal Pad The pad is designed to fit
The Issue: An internal review of an available product found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled...
The Issue: Zimmer Bioment Spine, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.