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 4221–4240 of 38,428 recalls
Recalled Item: Marodyne-LiV
The Issue: Some power supply units in Austria and Germany
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVP Primary Administration Set
The Issue: A defect may cause an uncontrolled medication flow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent IGM
The Issue: Firm identified two lots of reagents that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspire Model 4340 Respiratory Sensing Lead
The Issue: Labeling error with a mismatch between the shelf
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspire Model 4063 Stimulation Lead
The Issue: Labeling error with a mismatch between the shelf
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 620G Insulin Pump
The Issue: Insulin pumps that have been dropped, bumped, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed Insulin Pump Device. MiniMed 670G
The Issue: Insulin pumps that have been dropped, bumped, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 630G Insulin Pump
The Issue: Insulin pumps that have been dropped, bumped, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stainless Steel Sims Uterine Sound
The Issue: During the manufacturing process the devices were laser-marked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Silver-Plated Copper Sims Uterine Sound
The Issue: During the manufacturing process the devices were laser-marked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge
The Issue: During manufacturing, the last three tests from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
The Issue: The potential for biased quality control (QC) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)
The Issue: The potential for biased quality control (QC) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DR 800. Digital Radiography X-ray System.
The Issue: for the front lever chain of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial
The Issue: Reports have been received regarding open seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiomarC EX Fiducial Marker System
The Issue: This recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in
The Issue: Positive bias for some samples around the CA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in
The Issue: Positive bias for some samples around the CA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic
The Issue: Positive bias for some samples around the CA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in
The Issue: Positive bias for some samples around the CA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.