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 26361–26380 of 38,428 recalls
Recalled Item: BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit -
The Issue: Medline Industries, Inc. supplies Navilyst with sterile package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal
The Issue: Medline Industries, Inc. supplies Navilyst with sterile package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR
The Issue: Some Bipolar shells were manufactured with an out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LFIT Anatomic V40 Femoral Head
The Issue: Stryker received several complaints describing incidence of harm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR
The Issue: Some Bipolar shells were manufactured with an out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model...
The Issue: The ROI-A Anterior Delivery Device T-Handle, part number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter
The Issue: CONMED received complaints of damage to the CS-023
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriMed Semi-Tubular Plate
The Issue: TriMed is recalling the Semi-Tubular Plates with 10
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients
The Issue: The connector may disconnect from the tracheostomy tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS OptiBlue 1-Piece Intraocular Lens (IOL)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G1 Dissection Tool - 3mm CRS DBALL
The Issue: The firm discovered on March 4, 2016 that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS Symfony Extended Range of Vision IOL
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSAR Foldable IOL with OptiEdge Design
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G1 Dissection Tool - 3mm FLUTED BALL
The Issue: The firm discovered on March 4, 2016 that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSAR 1-Piece IOL
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G1 Dissection Tool - 6MM CRS DBALL
The Issue: The firm discovered on March 4, 2016 that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G1 Dissection Tool - 7mm FBALL L
The Issue: Product Code L- 7B-G1 was inadvertently released off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS Multifocal Foldable Acrylic Intraocular Lens
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.