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 16921–16940 of 38,428 recalls
Recalled Item: Euphoria Rapid Exchange Balloon Dilatation Catheter
The Issue: Medtronic has determined that some catheters have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achilles Express Bone Sonometer
The Issue: Certain Achilles Express and Achilles Insight systems were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achilles Insight Bone Sonometer
The Issue: Certain Achilles Express and Achilles Insight systems were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xhibit Central
The Issue: The firm received reports of loss of audio
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transducer S8-3t UDI (01)00884838073524 Can be used as
The Issue: The firm has discovered an issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transducer S7-3t UDI (01)00884838061439 Can be used with:
The Issue: The firm has discovered an issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transducer S8-3t UDI (01)00884838067523 Can be used with:
The Issue: The firm has discovered an issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transducer S7-3t UDI (01)00884838067530 Used as accessory with:
The Issue: The firm has discovered an issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPROTTE Lumbar with Introducer
The Issue: Problem with packaging sealing process which affects sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ApexPro Telemetry Server System. Also identified as Modification To: ApexPro
The Issue: May not provide visual and/or audible alarms at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dario Blood Glucose Monitoring System
The Issue: The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle
The Issue: The product do not meet certain internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NobelParallel Conical Connection NP
The Issue: The top label of article no. 37965, lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NavLock Tracker *** Rx Only
The Issue: Product was incorrectly assembled which could affect navigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle
The Issue: The product do not meet certain internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle
The Issue: The product do not meet certain internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion CIRCLAMP W/1.3 CM BELL-single-use
The Issue: A mismatch between the angle of the hole
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas c 701 and 702 Analyzer/Module-RF interference claims for the
The Issue: Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion CIRCLAMP W/1.1CM BELL - single-use
The Issue: A mismatch between the angle of the hole
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas c 311
The Issue: Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.