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 25581–25600 of 38,428 recalls
Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GoDirect Screw-Retaining Top Part Numbers: 4500-61
The Issue: Consignees received product 6060-62, Replant Overdenture Abutment with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous...
The Issue: Cook Medical has received reports of the trays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to
The Issue: Failure to correctly document the installation of four
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unna-Z
The Issue: Medline Industries, Inc is recalling Unna Z Unna
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NucliSENS magnetic extraction reagents
The Issue: A drift of the performance with the BK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MagSIL (NucliSENS easyMAG Magnetic Silica)
The Issue: A drift of the performance with the BK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i.v. Station and i.v. Station ONCO Automated Drug Compounding System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann Drill 1
The Issue: Drills cannot be inserted into handpiece due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann Twist Drill PRO ¿4.2mm
The Issue: Drills cannot be inserted into handpiece due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthex S3 Arm Sleeve Connector
The Issue: During use, the unit could separate un-expectantly. This
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQURE System Software Version 2.2.0 Model #: 933-599 UDI:...
The Issue: Design error when displaying additional information in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Durex Pleasure Pack . 3 ultra fine lubricated latex condoms
The Issue: Reckitt Benckiser LLC is recalling Durex Condoms Pleasure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Scope Power
The Issue: Siemens is providing a new installation of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior
The Issue: Absent tantalum market pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test
The Issue: Siemens is conducting this recall for the IMMULITE¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halo Closed System Transfer Device
The Issue: Product malfunction: Needle does not retract
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G3 Opticage Expandable Interbody Fusion Device
The Issue: During implantation, the proximal end of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.