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 14281–14300 of 38,428 recalls
Recalled Item: Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
The Issue: Exactech is recalling the Equinoxe Reverse Shoulder Compression
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
The Issue: Exactech is recalling the Equinoxe Reverse Shoulder Compression
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inquiry Steerable Diagnostic Catheter
The Issue: Steerable diagnostic catheter packages labeled Model IBI-81104, batch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inquiry Steerable Diagnostic Catheter
The Issue: Steerable diagnostic catheter packages labeled Model IBI-81104, batch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Imactis Patient Fiducial (Patient )
The Issue: The firm has received reports concerning the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOS Screws - Product Usage: is a part of the EVOS MINI plating system
The Issue: Multiple or incorrect expiration dates were provided on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SwiftHook sold as the following: a. Individually as SwiftHook b.
The Issue: Carry bar may detach during use of mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171
The Issue: Lack of sterility assurance of the 30-0171
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elecsys Anti-TPO Assay on cobas e analyzers 411
The Issue: Recent internal verification studies found the current RF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and
The Issue: Holding force of the Positioning Arm can be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICROFLEX Diamond Grip Examination Gloves
The Issue: Examination gloves were shipped inadvertently, without to verify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In
The Issue: Positive bias across the Analytical Measurement Range of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software: Syngo.via RT Image Suite software version VA30_SP02 with license
The Issue: Calibration offset between the central CT image plane
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UIBC
The Issue: The manufacturer has identified that the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC)
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description):
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number
The Issue: Various immunoassay enzymes failed product performance, thereby the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.