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 1281–1300 of 38,428 recalls
Recalled Item: ChemoLock Bag Spike
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical 60" (152 cm) Appx 1.2 ml
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemoLock Vented Vial Spike
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemoLock Universal Vented Vial Spike
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300....
The Issue: for compromised integrity of the sterile packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120....
The Issue: for compromised integrity of the sterile packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer
The Issue: Due to products that have not completed design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip
The Issue: Due to products that have not completed design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer
The Issue: Due to products that have not completed design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with
The Issue: GE HealthCare has identified an issue affecting Carescape"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with
The Issue: GE HealthCare has identified an issue affecting Carescape"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Branding is not applied to this product. Product
The Issue: Due to display cables used for monitors were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Branding is not applied to this product. Product
The Issue: Due to display cables used for monitors were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Branding is not applied to this product. Product
The Issue: Due to display cables used for monitors were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow Re-Direction Endoluminal Devices: FRED 27
The Issue: Flow diverter may have a manufacturing issue related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AW Server 2.0
The Issue: Firm has identified a security vulnerability in AW
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W...
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X...
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY
The Issue: Identified products were re-gassed (sterilized more than once)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.