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 8821–8840 of 38,428 recalls
Recalled Item: Plato 17 Microcatheter: Straight Tip
The Issue: Microcatheters for embolic coil and diagnostic agent introduction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Ultra-Fine Insulin Syringe 1mL
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Ultra-Fine Insulin Syringe 1mL
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel -
The Issue: Due to temperature excursions with products (products being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1)
The Issue: Due to temperature excursions with products (products being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml
The Issue: Nonsterile syringe potentially exposing the patient to pathogenic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In Vitro Diagnostic (IVD) Panel FilmArray GI Panel -
The Issue: Due to temperature excursions with products (products being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE.
The Issue: TFNA Femoral Nails labeled and etched as 200mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREAT NOBIL GRIP
The Issue: Product is labeled with an incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator
The Issue: Automated external defibrillators were potentially distributed with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOPHEN Protein C 5 kit is for in vitro quantitative
The Issue: New warnings and precautionary statements on product labelling:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution
The Issue: MiniCap Disconnect Cap with Povidone-Iodine are packaged in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fusion Bioline Vascular Graft
The Issue: One (1) Fusion Bioline Vascular graft from lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for
The Issue: Siemens Healthineers has received customer complaints and confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa COVID-19 Direct
The Issue: Direct amplification Discs , used with COVID-19 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog
The Issue: Product did not meet shelf-life testing requirements resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa Flu A/B & RSV Direct Gen II
The Issue: Direct amplification Discs , used with COVID-19 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For...
The Issue: After pressing and releasing the Z-Axis Motorized buttons
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the...
The Issue: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.