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 11141–11160 of 38,428 recalls
Recalled Item: Comprehensive Shoulder System Mini Humeral Stem
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder System Primary Shoulder Stem
The Issue: The products in scope underwent an incorrect rework
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock)
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Equipo de transferencia para DP MiniCap de vida util
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm))
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: Cleaning products, containing, but not limited to, hydrogen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition X (Product Number 781356) - HA FlexTrak II
The Issue: Magnetic materials were used for the wheels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory
The Issue: Magnetic materials were used for the wheels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X (Product Number 781358) - HA FlexTrak II
The Issue: Magnetic materials were used for the wheels of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Luer Lok Access Device - intended as a sterile
The Issue: May shed contaminant particles into the urine specimen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a
The Issue: May have adhesive residue on the posterior surface
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as
The Issue: May have adhesive residue on the posterior surface
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Veritor Plus Analyzer - intended to provide rapid test
The Issue: May have the potential to overheat and/or cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.