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 15701–15720 of 38,428 recalls
Recalled Item: Imager II 5F Angiographic Catheters
The Issue: for tip detachment of Imager II 5F
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Open Pivot Aortic Valve Graft
The Issue: Medtronic received a complaint from China that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intellijoint Navigation System
The Issue: During total knee arthroplasty (TKA), the software may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPICE (JWH-018) CC443
The Issue: Corrections are being made to the device labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology ECG Management
The Issue: Inaccurate estimation of the heart rate may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Stick Sponge Presaturated W/PVP DYND70288H 2/PK Expiration
The Issue: Voids were discovered in the packaging seal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle
The Issue: Voids were discovered in the packaging seal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Winged Sponges Presaturated W/PVP DYND70289H Expiration 06/30/2022.
The Issue: Voids were discovered in the packaging seal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis-
The Issue: Tomosynthesis image acquisition sequence did not stop automatically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ysio
The Issue: The Ysio system may process incorrect internal values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 88-Series-washer disinfectors intended for cleaning
The Issue: leakage that may occur due to ruptured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed...
The Issue: Sterile packaging may potentially be compromised, and use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Force TriVerse Electrosurgical Devices
The Issue: Sterile packaging may potentially be compromised, and use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuraGen Nerve Guide
The Issue: Nonconforming product which was dispositioned for rejection was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elecsys CA 19-9
The Issue: The firm has received an increased number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex System
The Issue: Baxter is communicating safety information from the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex System
The Issue: Baxter is communicating safety information from the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex System
The Issue: Baxter is communicating safety information from the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex System
The Issue: Baxter is communicating safety information from the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex System
The Issue: Baxter is communicating safety information from the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.