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 8761–8780 of 38,428 recalls
Recalled Item: DeRoyal SafeLiner Suction Canister
The Issue: The reason for the voluntary recall is due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX
The Issue: for packaging non-conformances directly related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm
The Issue: The packaging may be damaged, compromising the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS HF System PA Sensor and Delivery System
The Issue: Select CardioMEMS PA Sensors (Model CM2000) operate outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
The Issue: There have been reported failures of the high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS HF System PA Sensor and Delivery System
The Issue: Select CardioMEMS PA Sensors (Model CM2000) operate outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31
The Issue: Firm has received reports of damaged, worn, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue. Model Number: 0998-00-0800-83.
The Issue: Firm has received reports of damaged, worn, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33...
The Issue: An unexpected shutdown of the IABP may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.