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 12721–12740 of 38,428 recalls
Recalled Item: Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS.
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIGH PRESSURE TUBING
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELI 280 Electrocardiograph
The Issue: Devices do not meet IEC 60601-2-27 requirements as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELI 380 Electrocardiograph
The Issue: Devices do not meet IEC 60601-2-27 requirements as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mark 910 LogiCal
The Issue: Specific lots of Medex High Pressure Adaptors, Rotators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis systems - Product Usage: an angiography systems developed for
The Issue: Due to inappropriate cleaning, some Artis systems show
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnia Soft Tissue Punch is a dental instrument designed to
The Issue: Omnia SRL received a notification from the contract
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 -
The Issue: Not manufactured to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 -
The Issue: Not manufactured to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product
The Issue: Not manufactured to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 -
The Issue: Not manufactured to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 -
The Issue: Not manufactured to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Provox Life Night HME
The Issue: Provox Life Night HME may be incorrectly inserted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator.
The Issue: Randox can confirm a positive bias for Total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for
The Issue: 3/4 AFT Straight Fill Tubes (227007) filled only
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75
The Issue: VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Xper Flex Cardio (FC2010
The Issue: Performance issues with the Xper Flex Cardio Physio
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized
The Issue: Radiometer has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.