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 12901–12920 of 38,428 recalls
Recalled Item: ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FREESTYLE LANCETS 28G 100CT Item Number:2975670
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
The Issue: Due to shipping delays the devices were exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 60mL Syringe w/Spinning Spiros
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx 3.3 mL
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncology Kit w/60" (152 cm) Appx 2.2 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncology Kit w/Spiros¿
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5 IN (13cm) APPX 0.57 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx 3.2 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx 6.1 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spiros" Closed Male Luer - Product Usage: provides
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 180 cm (71 IN)APPX 11.5ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 40" (102 cm) Appx. 4.8 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 42 cm (16.5 IN) APPX 2.6ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 35" (89 cm) Appx 3.9 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spinning Spiros¿ Closed Male Luer
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.