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 35661–35680 of 38,428 recalls
Recalled Item: pocH-100i
The Issue: The data printed on the thermal printer may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA Analyzer Pipette Tips used on Tosoh AIA-2000
The Issue: Visual inspection of the pipette tips indicated that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Two Lead Arthroscopic Irrigation Set
The Issue: A firm's internal investigation led to the discovery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Four Lead TUR irrigation Set
The Issue: A firm's internal investigation led to the discovery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Four Lead Arthroscopic Irrigation Set
The Issue: A firm's internal investigation led to the discovery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Superior Approach Resection Guide Assembly. Indicated for primary
The Issue: Biomet has initiated this action following an investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comfort brand Ear-Loop Face Mask
The Issue: Recent Lab testing conducted in March 2013 indicates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100
The Issue: Customers could potentially experience intermittent, unintended and illogical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood
The Issue: The specified part numbers and lot numbers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm)
The Issue: A component Superior endplate manufactured from a different
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Delta Vaporizer An anesthetic vaporizer is a device used to
The Issue: It has come to Penlon Ltd's attention of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22
The Issue: Edwards is recalling the QuickDraw Venous Cannula due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optovue iVue with Normative Database (NDB) with Software Version 3.0
The Issue: Colors from the NDB comparison for Ganglion Cell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests
The Issue: iPTH Assay- reagent and calibrator lots may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canister: CO2 canister with GE part numbers 1407-3200-000
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ iPTH Calibrator 6 pk
The Issue: iPTH Assay- reagent and calibrator lots may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur iPTH Calibrator 2 pk
The Issue: iPTH Assay- reagent and calibrator lots may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests
The Issue: iPTH Assay- reagent and calibrator lots may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NuOss XC Sinus No 509-3001 (BMCU17
The Issue: During the 36 month real time shelf life
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HSV 2 Primers
The Issue: Firm received complaints that HSV-2 primers failed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.