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 24081–24100 of 38,428 recalls
Recalled Item: Her2/Neu (c-erbB-2) (CB-1 1)
The Issue: Cell Marque has determined the need to issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opteryx Variable Rescue Screw
The Issue: Opteryx Variable Rescue Screws are engraved with incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kii Shielded Bladed trocars (CTB14)
The Issue: Due to possibility of insufficient sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NMT Patient Cable (989803174581) in use with lntelliVue NMT Module
The Issue: Manufacturing defect may cause localized heating, which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCHRITTMACHER ANGIO X3
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUSTOM SUTURE PACK
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiLite Multi-Use Holmium Laser Fibers
The Issue: Cook Inc. is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Best Practice Kit
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: USPACK-SUTURE KIT
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R
The Issue: for an incomplete seal on the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vue Optic Visualization Source
The Issue: Cook Inc. is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestation 620 A1
The Issue: Carestation 620, 650 and 650c has Potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
The Issue: Implant Direct Sybron Manufacturing is recalling the Legacy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arietta 70 Ultrasound System Intended for use by trained personnel (doctor
The Issue: The strength of the arm mounting mechanism was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device....
The Issue: Robot arm being sent to the wrong position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device....
The Issue: Robot arm being sent to the wrong position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APLIO 500 TUS-A500 diagnostic ultrasound system
The Issue: When Continuous Trace method is used as the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.