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 14241–14260 of 38,428 recalls
Recalled Item: AltiVate Reverse Small Socket Insert
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Langston Dual Lumen Catheter.
The Issue: The inner lumen of the Langston catheter may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Langston Dual Lumen Catheter
The Issue: The inner lumen of the Langston catheter may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to
The Issue: The CHF-CB30S Device did not have a 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Langston Dual Lumen Catheter.
The Issue: The inner lumen of the Langston catheter may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Langston Dual Lumen Catheter.
The Issue: The inner lumen of the Langston catheter may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BELLATEK TITANIUM ABUTMENT 4.1MM Number: EDAT4
The Issue: Hex of the BellaTek Encode Definitive Abutments was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material...
The Issue: for Fluid leaks within the instruments, creating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Numbers: 3DPMSER
The Issue: Hex of the BellaTek Encode Definitive Abutments was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pediatric Nephrostomy Stent Set
The Issue: The indwell time for the Percutaneous Neonatal Pigtail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Neonatal Pigtail Nephrostomy Set
The Issue: The indwell time for the Percutaneous Neonatal Pigtail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for...
The Issue: Brainlab Ultrasound Navigation Software does not support the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Number: IEDAT5
The Issue: Hex of the BellaTek Encode Definitive Abutments was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK TIN ABUTMENT 4.1MM Number: IEDAN4
The Issue: Hex of the BellaTek Encode Definitive Abutments was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Number: IEDAT4
The Issue: Hex of the BellaTek Encode Definitive Abutments was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
The Issue: for Fluid leaks within the instruments, creating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Number: IEDAT6
The Issue: Hex of the BellaTek Encode Definitive Abutments was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PermaFlo Flowable Composite 948 Shade: A2 - Product Usage:
The Issue: Due to a potential manufacturing issue (cross contamination),
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK TIN ABUTMENT 5.0MM Number: IEDAN5
The Issue: Hex of the BellaTek Encode Definitive Abutments was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope...
The Issue: The BF-Q180 bronchoscope is being recalled because it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.