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 2521–2540 of 38,428 recalls
Recalled Item: MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP
The Issue: Medline ReNewal has identified that the drip chambers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand
The Issue: Medline ReNewal has identified that the drip chambers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality Instrument Check Block
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker HoloBlueprint Application
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ReNewal ENT Coblator II PROcise mAx
The Issue: Medline ReNewal has identified that the drip chambers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality Glenoid Box Lid
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InPen smart insulin pen
The Issue: Insulin pens may have been incorrectly assembled therefore
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID NOW Influenza A/B 2 24T Product Name:
The Issue: the impacted lots have a higher occurrence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID NOW RSV 24T Product Name: ID NOW
The Issue: the impacted lots have a higher occurrence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID NOW Influenza A/B 2 24T Product Name:
The Issue: The impacted lots have a higher occurrence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID NOW COVID-19 2.0 24T Product Name: ID
The Issue: the impacted lots have a higher occurrence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT
The Issue: AutoPulse NXT Resuscitation System may not provide adequate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID NOW RSV 24T Product Name: ID NOW
The Issue: The impacted lots have a higher occurrence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID NOW COVID-19 2.0 24T Product Name: ID
The Issue: The impacted lots have a higher occurrence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stimulation RC Clinician Programmer Application
The Issue: There is a software issue that can permanently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis
The Issue: product mix-up; Vascular stent labeled as one size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis
The Issue: product mix-up; Vascular stent labeled as one size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Latitude EV HUMERAL REVISION STEM TRIAL
The Issue: A specific lot of Latitude Humeral Trial Stems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits used for various procedures: 1) NAIL PACK
The Issue: There is a potential for open/weak seals on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.