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 22321–22340 of 38,428 recalls
Recalled Item: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product
The Issue: Due to FDA's safety communication relating to nontuberculous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM
The Issue: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM
The Issue: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM
The Issue: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM
The Issue: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM
The Issue: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM
The Issue: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM
The Issue: Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U2 Total Knee System Tibial Insert
The Issue: UOC received a customer compliant report from our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U2 Total Knee System Tibial Insert
The Issue: UOC received a customer compliant report from our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo Lap-Band AP System Small with RapidPort EZ Product Usage:
The Issue: Component of the Lap-Band system was missing from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.