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 23101–23120 of 38,428 recalls
Recalled Item: Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product
The Issue: The 7mm diameter uniaxial pedicle screws have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Processor 1K Stockyard. The Power Processor performs all pre-analytical
The Issue: Beckman Coulter has identified that due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Saver 5/5+ Bowl Set
The Issue: Haemonetics has received isolated reports that in some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Saver Elite Processing Kit
The Issue: Haemonetics has received isolated reports that in some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemosll ReadiPlasTin (20 ml Size)
The Issue: Instrumentation Laboratory Co. received customer reports of performance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JANUS & JANUS G3 Automated Workstation is an automated programmable
The Issue: We have become aware through internal testing that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel
The Issue: Two users have reported to OriGen that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Firebird NXG Spinal Fixation System Decorticating Planer
The Issue: The plastic core of the Decorticating Planer was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT
The Issue: Two lots of Genesis II Non Porous C/R
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Segmental System
The Issue: The products being recalled exceeded the weight previously
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled
The Issue: The products being recalled exceeded the weight previously
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource(R) Kits (custom surgical/procedural kits): The standard and custom...
The Issue: The firm manufactured and distributed Presource(R) kits which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 140" (356 cm) Y-Type Blood Set w/170 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lopez Valve¿ w/Red Cap
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 98" (249 cm) Y-Type Blood Set w/170 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter
The Issue: Some devices were labeled as Does not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.