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 8841–8860 of 38,428 recalls
Recalled Item: Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative...
The Issue: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Total Protein II- In vitro diagnostic use in
The Issue: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative
The Issue: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N)
The Issue: An increased incidence of damage to the nut
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
The Issue: Manufactured with misaligned axis resulting in lenses with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens
The Issue: Manufactured with misaligned axis resulting in lenses with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Easy Read App associated with First Response Pregnancy Test Sticks
The Issue: Church & Dwight First Response Pregnancy Kits was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEMA Axle Small
The Issue: Due to the incorrect component, that is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tri-Staple 2.0 Black Intelligent Reload
The Issue: Affected lots have the potential for a broken
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the
The Issue: Triton Canister Software, Insert & Scanning Label may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Life2000 Ventilator PKG
The Issue: There is the potential for patient desaturation events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Finished Goods Box of 50 Inserts and Scanning Labels for
The Issue: Triton Canister Software, Insert & Scanning Label may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Life2000 Ventilator PKG
The Issue: There is the potential for patient desaturation events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Life2000 Ventilator System
The Issue: There is the potential for patient desaturation events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Finished Goods Box of 50 Inserts and Scanning Labels for
The Issue: Triton Canister Software, Insert & Scanning Label may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Life2000 Ventilator
The Issue: There is the potential for patient desaturation events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a
The Issue: An observed trend of high conductivity dialysate alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Side Cart
The Issue: Preventative maintenance data was used to identify instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards
The Issue: Infusion pump PCs with specific software/network cards/IP addresses
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaStar TS
The Issue: The magnets used in the swivel frame/tube set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.