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 27761–27780 of 38,428 recalls
Recalled Item: The Vesa 75/100 adaptation with rotation is an accessory to
The Issue: Supplier of the "VESA 75 / 100 adaptation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive)
The Issue: Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute
The Issue: Dialyzer header leak due to possible improper torque
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Symbia gamma camera system Product Usage: The Symbia gamma
The Issue: We received a customer complaint that Siemens reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The E.CAM gamma camera system Product Usage: The E.CAM gamma
The Issue: We received a customer complaint that Siemens reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: system
The Issue: In Artis zeego systems, angulations in the vicinity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Xhibit Central Station
The Issue: The firm has received one report of values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TeleSentry Battery
The Issue: The firm received a complaint of the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx. 3.3 ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx. 6.3 ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx. 3.3 ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 31" (79 cm) Appx. 3.4 ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx 3.6 ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 110" (279 cm) Appx 13.8 ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 74" (188cm) approximately 9.0ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx 6.3 ml
The Issue: ICU Medical has identified an issue with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PureWick External Catheter for Women-Wick Product Usage: A flexible
The Issue: PureWick is recalling external catheter for women Wicks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00
The Issue: During a procedure the Peak Skin Dose (PSD)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 )
The Issue: Product insert fails to identify performance limitation related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.