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 36441–36460 of 38,428 recalls
Recalled Item: NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm
The Issue: The 1.6 mm Guidewire is undersized up to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventri Discovery NM 530c
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esteem Programmer Model 6001
The Issue: Envoy Medical is conducting a voluntary correction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and
The Issue: Neonatal beds and incubator display boards may randomly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh...
The Issue: Product is dual packaged in an inner and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The
The Issue: There is a potential for erosion of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns high-flow aortic arch cannula
The Issue: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns flexible arterial cannula
The Issue: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns high-flow aortic arch cannula
The Issue: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns flexible arterial cannula
The Issue: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns high-flow aortic arch cannula
The Issue: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns flexible arterial cannula
The Issue: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product is labeled in part "***Surgical Laser Technologies
The Issue: Firm became aware that some products within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are
The Issue: DePuy Orthopaedics is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are
The Issue: DePuy Orthopaedics is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are
The Issue: DePuy Orthopaedics is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.