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 10521–10540 of 38,428 recalls
Recalled Item: MiniMed 620G Insulin Pump (O.U.S. version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 630G Insulin Pump (U.S. and Canada Version)
The Issue: Due to battery cap deterioration, this may potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EIT CIF cage
The Issue: Label on the Outer Carton does not match
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Item Number: 800774001
The Issue: A nonsterile component was packaged in a sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Globe-Trotter and Globe-Trotter IC
The Issue: The firm has initiated this recall to replace
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis)
The Issue: Label provided for substrate vail contained incorrect expiration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System
The Issue: for stent dislodgement and associated failures related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Icono
The Issue: During system tests, an increased wearing of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the...
The Issue: High number of total images/unassigned events including (dual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EIT CIF cage
The Issue: Label on the Outer Carton does not match
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MassCheck Amino Acid
The Issue: Too low concentration of glycine was detected in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MassCheck Amino Acid
The Issue: Too low concentration of glycine was detected in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensica Urine Output System
The Issue: Complaints relating to urine output measurement accuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paragon 28
The Issue: Incorrect labeling; There is potential that the drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODULAR CATHCART FRACTURE HEAD HIP BALL
The Issue: The Cathcart Ball has an inherent +5mm offset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension LTNI -In vitro diagnostic test intended to quantitively measure
The Issue: Positive bias with Lithium Heparin plasma samples from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac
The Issue: Positive bias with Lithium Heparin plasma samples from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
The Issue: There is a potential for sporadic incidents of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3D Systems VSP Reconstruction
The Issue: Scapula Marking Guide (anatomically Shaped) was incorrectly designed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: #1 MAC F/O LARYNGOSCOPE
The Issue: Packaging error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.