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 21541–21560 of 38,428 recalls
Recalled Item: Intera 1.0T
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns TCM
The Issue: Update to cooler-heater cleaning instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo HX2 Temperature Management System
The Issue: Update to cooler-heater cleaning instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T5 Model 78104 Product Usage: Indicated for use as a
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare: a) Prodigy
The Issue: Under certain conditions, when using DICOM Worklist along
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URO-3 Triple Stain (CD44 + p53) with CK20
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar
The Issue: Devices were found with a sterile breach (puncture)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Normed Charcot Osteotome Chisel (Various sizes)
The Issue: Product may contain a gap between the handle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174
The Issue: These products contain latex, but the following statement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a)...
The Issue: These products contain latex, but the following statement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rectal Catheters
The Issue: These products contain latex, but the following statement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316
The Issue: These products contain latex, but the following statement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WRIGHT
The Issue: Tow lot of VALOR(TM) Nail could potentially be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart FRx AED.
The Issue: An issue with one of the electric components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect simply InterActive Implant
The Issue: The cap on the vial might be labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart (HS1) Onsite/Home AED
The Issue: An issue with one of the electric components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHILIPS Xper Flex Cardio Physiomonitoring System
The Issue: The real-time numeric value for ventricular end-diastolic pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision
The Issue: After continuous operation for more than one and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PTS Panels¿ CHOL+GLU Test Strips ()
The Issue: for loss of activity of the glucose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.