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 23321–23340 of 38,428 recalls
Recalled Item: AVID Medical QA Pack AV10654-10
The Issue: The swab stick collection device provided in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heron toilet and bath chair Model 880505-01 & 880505-11
The Issue: Replacement campaign on all units that have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
The Issue: For soft tissue fixation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
The Issue: Product may contain the presence of melted sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 731 Series Ventilators running software version 05.20.00 The devices in
The Issue: A software anomaly in the 731 software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Medical Charged-Particle Radiation Therapy System
The Issue: The table shift in the vertical direction was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORA System with VerifEye+ Cart
The Issue: Some ORA Carts have the potential to return
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORA System with VerifEye
The Issue: Some ORA Carts have the potential to return
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaSafe Plastic Cannula - 11 Gauge
The Issue: Punctures in blister packaging that was detected during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOCKERT Heater-Cooler System 3T
The Issue: Plastic heat exchanger fibers separating the blood compartment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOCKERT Heater-Cooler System 3T
The Issue: Plastic heat exchanger fibers separating the blood compartment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOCKERT Heater-Cooler System 3T
The Issue: Plastic heat exchanger fibers separating the blood compartment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOCKERT Heater-Cooler System 3T
The Issue: Plastic heat exchanger fibers separating the blood compartment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOCKERT Heater-Cooler System 3T
The Issue: Plastic heat exchanger fibers separating the blood compartment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOCKERT Heater-Cooler System 3T
The Issue: Plastic heat exchanger fibers separating the blood compartment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens...
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PPS RingLoc+ Acetabular Shell
The Issue: Device was distributed with the etching missing from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Thyroxine (T4) assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Ammonia (AMM) chemistry assay
The Issue: Various assays used to measure different chemical levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.