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 19601–19620 of 38,428 recalls
Recalled Item: Aisys CS2 Anesthesia System. Sold under the following product names: AISYS
The Issue: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Touchscreen display kit. Sold under the following product names: TOUCHSCREEN
The Issue: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFUSE Bone Graft X SMALL KIT
The Issue: The Extra Small INFUSE Bone Graft kit from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical
The Issue: Multiple Issues Identified in Atellica Solution System Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical
The Issue: Multiple Issues Identified in Atellica Solution System Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical
The Issue: Multiple Issues Identified in Atellica Solution System Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica Sample Handler Prime. In vitro diagnostic testing of clinical
The Issue: Multiple Issues Identified in Atellica Solution System Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation...
The Issue: An incorrect display of the Biopsy Depth Gauge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife M6
The Issue: A robotics supplier notified Accuray of two manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCEA Kit ASV Yellow Stripe Microbore
The Issue: The products have the potential to leak between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TB Series Bipolar Pacing Leads
The Issue: During the use of some TB - Temporary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCEA ASV Yellow Microbore
The Issue: The products have the potential to leak between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack
The Issue: Visual particulates within a battery Tyvek pouch. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Incubator Carestation. Neonatal incubator. Device sold under the...
The Issue: electric leakage affecting the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panda Freestanding Warmer. Device sold under the following product names:
The Issue: electric leakage affecting the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following
The Issue: electric leakage affecting the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Warmer. Device sold under the following product names: Giraffe
The Issue: electric leakage affecting the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panda iRes Infant Radiant Warmer. Device sold under the following
The Issue: electric leakage affecting the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panda Wall Mount warmer. Infant radiant warmer
The Issue: electric leakage affecting the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part
The Issue: Incorrect package labeling identifying the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.