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 28621–28640 of 38,428 recalls
Recalled Item: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm
The Issue: Some of the Blood Collection Tubes in these
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm
The Issue: Some of the Blood Collection Tubes in these
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm
The Issue: Some of the Blood Collection Tubes in these
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm
The Issue: Some of the Blood Collection Tubes in these
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm
The Issue: Some of the Blood Collection Tubes in these
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Best Practice Kits containing certain production lots of Endo GIA
The Issue: Staplers fail to fire or partially fire and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRN 50-M+
The Issue: The item was recalled due to an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle
The Issue: Staplers fail to fire or partially fire and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle
The Issue: Staplers fail to fire or partially fire and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Endo GIA Ultra Universal Standard Stapler Handle
The Issue: Staplers fail to fire or partially fire and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for
The Issue: The hardware that holds the VESA plate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Label reading in part as: "NexGen System
The Issue: Complaints were received from Thailand reporting that there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Black Mamba Suture Passer
The Issue: There may be a separation and an insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Green Mamba Suture Passer
The Issue: There may be a separation and an insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set
The Issue: The Lactobacillus acidophilus negative control (item 0243 single
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set
The Issue: The Lactobacillus acidophilus negative control (item 0243 single
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PS-500 Scope Warmer
The Issue: Damage to package seals potentially compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Coban Self-Adherent Wrap Shipper carton label identified the product
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNTHES
The Issue: The 13.5mm Medullary Reamer head, lot #F-17180, is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CNSystems TASK FORCE MONITOR 3040i
The Issue: Device non-conformity which may lead to an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.