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 5701–5720 of 38,428 recalls
Recalled Item: DURAFLOW 2
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Allia IGS 7 OR
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAFLOW 2
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Interact Discovery RT
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAFLOW 2
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Allia IGS 5 Pulse
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAFLOW 2
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 5
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Allia IGS 7
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAFLOW 2
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 6
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Allia IGS 5 Pulse
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 24CM STR. BASIC KIT
The Issue: Tri-Ball Tunneler may contain loosely affixed metal shavings,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightStrike Blackout Curtains
The Issue: Blackout curtains are no longer recommended as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERLA TL 25D SCREW 45 25-S TLF-DS 45
The Issue: Due to receiving information regarding difficulties with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Seprafilm Adhesion Barrier 1 Half Sheet
The Issue: Product was distributed in the United States without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm)
The Issue: Products may not be heparin coated as indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.