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 5741–5760 of 38,428 recalls
Recalled Item: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number:
The Issue: Received complaints that bottles assembled with one batch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number:
The Issue: Received complaints that bottles assembled with one batch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Iron3 - IVD use in the quantitative measurement
The Issue: for falsely elevated Chol_2, LDLC, and Trig_2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Cart
The Issue: Surgical system may have inadequately welded top and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0T
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 7700
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GYROSCAN T5
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera Achieva 1.5T Pulsar
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0TX for PET
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Namic FLUID DELIVERY SET
The Issue: Products have a lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: namic CONVENIENCE KIT
The Issue: Products have a lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T R11
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Initial
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Omni/Stellar
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T S
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GYROSCAN T5-NT
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Achieva Nova
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Achieva IT Nova
The Issue: Patient support table floor plate may be incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.