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 19281–19300 of 38,428 recalls
Recalled Item: da Vinci X Surgical System
The Issue: Due to a manufacturing variation in the arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Ferritin Reagent Kit
The Issue: Abbott has become aware of a manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits
The Issue: that product has not reached complete sterilization,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i TSH Reagent Kit
The Issue: Abbott has become aware of a manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Progesterone Reagent Kit
The Issue: Abbott has become aware of a manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Total Beta-hCG Reagent Kit
The Issue: Abbott has become aware of a manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Estradiol Reagent Kit
The Issue: Abbott has become aware of a manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Free T4 Reagent Kit
The Issue: Abbott has become aware of a manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i 25-OH Vitamin D Reagent Kit
The Issue: Abbott has become aware of a manufacturing issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power-LOAD Cot Fastening System
The Issue: The power load floor plates which hold the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet DVR Crosslock Screws- 2.7mm x 20mm
The Issue: One lot of product labeled 2.7mm x18mm Lock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet DVR Crosslock Screws- 2.7mm x18mm
The Issue: One lot of product labeled 2.7mm x18mm Lock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St. Jude Medical Confirm Rx Insertable Cardiac Monitor
The Issue: The device is unable to pair with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrex Suture Anchor
The Issue: Potentially lead to anchor breakage during insertion,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SP CAL (LIQ)
The Issue: Calibrator value sheets have been modified for assigned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US
The Issue: HVAD Battery Charger units manufactured with wrong inductors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medex High Pressure Stopcock used to control the direction of
The Issue: Certain lots of Medex" High Pressure Stopcocks were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cyberonics VNS Therapy AspireSR
The Issue: This recall is an expansion of Z-3019-2017 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cyberonics VNS Therapy AspireHC Model 105 Generator
The Issue: This recall is an expansion of Z-3019-2017 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2
The Issue: This recall is being initiated due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.