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 29521–29540 of 38,428 recalls
Recalled Item: Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50
The Issue: Firm determined that some lots of CT/NG Swab
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trumpf Ceiling Mounted Surgical Lighting Systems
The Issue: Complaints received of the front joint of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trumpf Ceiling Mounted Surgical Lighting Systems
The Issue: Complaints received of the front joint of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trumpf Ceiling Mounted Surgical Lighting Systems
The Issue: Complaints received of the front joint of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trumpf Ceiling Mounted Surgical Lighting Systems
The Issue: Complaints received of the front joint of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas Liat Analyzer
The Issue: Due to a supplier issue, the incorrect green
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic EOPA Arterial Cannula
The Issue: EOPA Arterial Cannula Devices in this lot were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems
The Issue: The software is unable to accurately determine the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips GoSafe Mobile Help Button
The Issue: Irregular battery disconnection resulted in issues with Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/MR
The Issue: Philips Healthcare has become aware of a problem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC)
The Issue: customers are receiving a high number of Abnormal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare TraumaDiagnost
The Issue: If arm is not fastened securely it could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft
The Issue: Biomet has initiated a recall on Biomet Spine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano Pioneer Plus Re-Entry Catheter
The Issue: Due to a manufacturing defect, there is the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COULTER ISOTON 4 Diluent
The Issue: Beckman Coulter is recalling the LH 750 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COULTER LH Series Diluent
The Issue: Beckman Coulter is recalling the LH 750 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Application Instrument for Sternal ZIPFIX
The Issue: The end cap may loosen and detach making
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian Real-Time Monitor
The Issue: Medtronic MiniMed is recalling the Guardian Real-Time Continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm
The Issue: These screws have a potential of passing through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm
The Issue: These screws have a potential of passing through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.