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 16241–16260 of 38,428 recalls
Recalled Item: Arrow Endurance" Extended Dwell Peripheral Catheter System
The Issue: sterility issue for specific lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mazor X Surgical System Positioner Type II
The Issue: There is a potential for the surgical system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker T2 Alpha Delta Strike Plate IMN Instruments - part
The Issue: Instrument can break at the level of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI:...
The Issue: The stiffness of the soft end of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI:...
The Issue: The stiffness of the soft end of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
The Issue: An issue with the Lunar iDXA control panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lunar iDXA bone densitometer
The Issue: An issue with the Lunar iDXA control panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
The Issue: An issue with the Lunar iDXA control panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
The Issue: An issue with the Lunar iDXA control panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech equinoxe PLATFORM FRACTURE
The Issue: Labels with incorrect translations were identified by Exactech
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech equinoxe PLATFORM FRACTURE
The Issue: Labels with incorrect translations were identified by Exactech
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healon GV PRO 0.85 mL
The Issue: Ophthalmic viscosurgical device may be difficult to remove
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive
The Issue: A loose ODU plug / Coaxial cable connection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PuraSinus Absorbable Nasal Hemostat
The Issue: The boxes used by the shipper were not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPince Full Core Biopsy Instrument 16ga x 15cm.
The Issue: Incorrect product labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PTS Diagnostics CardioChek Plus Professional Analyzer
The Issue: One brand of batteries have a small dimensional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein CardioChek Starter Kit
The Issue: One brand of batteries have a small dimensional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PTS Diagnostics CardioChek Plus Professional Analyzer
The Issue: One brand of batteries have a small dimensional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein CardioChek Plus Professional Analyzer
The Issue: One brand of batteries have a small dimensional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Thermistor Foley Catheter 14 FR 5-10 ml
The Issue: Temperature deviation did not meet release specifications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.