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 30781–30800 of 38,428 recalls
Recalled Item: da Vinci S Surgical System IS2000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgical System IS3000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgical System IS3000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System IS2000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System IS2000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgical System IS3000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S / Si Surgical System IS2000 / IS3000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System IS2000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgical System IS3000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S / Si Surgical System IS2000 / IS3000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRATIFY JCV DxSelect
The Issue: Focus Diagnostics is recalling the Stratify JCV Dx
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery...
The Issue: IFU missing contraindications: Patients with uncontrolled sepsis and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube
The Issue: Crystals may be observed in the R1 reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebola IgX VP-40 Serum/Plasma/Blood Cassette
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nuclear Gamma Cameras (ADAC Vertex Classic
The Issue: During clinical use of a Vertex Plus Gamma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Introduction Pack. A device inserted into an endotracheal tube to
The Issue: Vital Signs Colorado (dba CareFusion) is recalling Vital
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerLoc MAX Safety Winged Infusion Set
The Issue: Bard Access Systems is conducting a field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ebola Accessories assembled
The Issue: LuSys Laboratories is recalling Ebola Virus One Step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion Vital Signs LightWand Stylet. A device inserted into an
The Issue: Vital Signs Colorado (dba CareFusion) is recalling Vital
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use
The Issue: A lot of Flowable Wound Matrix that has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.