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 24461–24480 of 38,428 recalls
Recalled Item: SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for
The Issue: Complaints concerning kinked haptics that were occurring during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems Insulin Calibrator
The Issue: Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE
The Issue: Complaints regarding broken blister
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The JETSTREAM is a rotational atherectomy catheter system designed for
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: "Free and Total Protein S ELISA Kit" Cat. No. 5292
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroVue CIC-C1q EIA
The Issue: There is a potential for the slope of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jelco
The Issue: Smiths Medical became aware on January 11, 2017,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellex Tango with slit lamp Laser Ophthalmic In the SLT mode
The Issue: It was discovered the unit produced a laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solus Flexible wire-reinforced laryngeal mask airways under the following sizes:
The Issue: A defect in the wire-reinforced tubing may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enzymatic Creatinine Reagent (CR-E 2 x 200)
The Issue: Beckman Coulter has identified the following drugs as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salicylate Reagent (SALY 2 x 45)
The Issue: Beckman Coulter has identified the following drugs as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HDL Cholesterol Reagent (HDL 2 x 200)
The Issue: Beckman Coulter has identified the following drugs as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cholesterol Reagent(CHOL 2 x 300)
The Issue: Beckman Coulter has identified the following drugs as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triglycerides Reagent (TG 2 x 300)
The Issue: Beckman Coulter has identified the following drugs as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uric Acid Reagent (URIC 2 x 300)
The Issue: Beckman Coulter has identified the following drugs as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactate Reagent (LACT 2 x 50)
The Issue: Beckman Coulter has identified the following drugs as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mederi Stretta Catheter and Accessory Kit
The Issue: Product sterility compromised due to breach in sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between
The Issue: The second generation neoBLUE 2 lights with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUIOS CL Flow Cytometer
The Issue: Beckman Coulter has confirmed that the Export feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healon GV
The Issue: Remote possibility that certain solutions in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.