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 17001–17020 of 38,428 recalls
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog
The Issue: Due to device overhang issue that protrudes beyond
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral
The Issue: Due to device overhang issue that protrudes beyond
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog
The Issue: Due to device overhang issue that protrudes beyond
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog
The Issue: Due to device overhang issue that protrudes beyond
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEEP Return Patient Pads (10/ box) Model # 6050Pl used
The Issue: Discrepancy between the correct expiration dates on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: The femoral impactors have a higher than normal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Irrisept Wound Debridement and Cleansing System. 12 units per case.
The Issue: defect in the sterile pouch seal, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bioseal Trachea Extender 1/pl 50pk/Cs
The Issue: The reported stress crack in the port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remisol Advance running on hardware with Windows XP
The Issue: A patch was released for a critical remote
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triglycerides Reagent (TG 2 x 300)
The Issue: It has been determined that N-acetyl p benzoquinone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enzymatic Creatinine Reagent (CR-E 2 X 200)
The Issue: It has been determined that N-acetyl p benzoquinone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uric Acid Reagent (URIC 2 X 300)
The Issue: It has been determined that N-acetyl p benzoquinone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400)
The Issue: It has been determined that N-acetyl p benzoquinone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300)
The Issue: It has been determined that N-acetyl p benzoquinone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grab n Go Opti series VIPR system Model # PRX-9646
The Issue: Limited access to flow settings as a result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grab n Go Opti series VIPR system Model # PRX-9653
The Issue: Limited access to flow settings as a result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.