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 29921–29940 of 38,428 recalls
Recalled Item: Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus
The Issue: Cochlear Americas is recalling Nucleus Sterile Silicone Template
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panoramic X-ray Model PC-1000 The PC-1000 will enable the user
The Issue: Jackscrew nut part failure potentially leading to device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APEX INTERFACE Hemi 54X and Flared 56X
The Issue: The device may have improper screw hole placement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THOMAS by Gardner Denver
The Issue: Vacuum pump may not perform to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THOMAS by Gardner Denver
The Issue: Vacuum pump may not perform to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THOMAS by Gardner Denver
The Issue: Vacuum pump may not perform to specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S.
The Issue: Sterile packaging was not sealed. The implantation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. Foot Locking Calcaneus Plate
The Issue: The thread location on one of the thread
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Emotion 6
The Issue: A potential safety issue involving two (2) broken
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Emotion 16
The Issue: A potential safety issue involving two (2) broken
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical Prelude Pro Sheath Introducter
The Issue: Some of these introducer sheaths were packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prestige Plus 185cm J-Tip: Part number: 9185J
The Issue: During a relabeling procedure at the manufacturing facility,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano PV .035 Catheter: Part number: 88901
The Issue: During a relabeling procedure at the manufacturing facility,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD
The Issue: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR
The Issue: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR
The Issue: The firm observed that the BIRMINGHAM HIP(TM) Resurfacing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Medley LVP Frame Membrane. Intended use to hold platen
The Issue: Administration of inappropriate quantities of fluid can result,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Medley LVP Bezel Assembly. Intended use to hold platen
The Issue: Administration of inappropriate quantities of fluid can result,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer WIZARD2 10-detector
The Issue: Error in WIZARD2 Barcode ID Label #023 Content
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer WIZARD2 1-detector
The Issue: Error in WIZARD2 Barcode ID Label #023 Content
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.