FDADecember 28, 2016device
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histol...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product sterility compromised due to breach of sterile barrier
What to do
FDA enforcement status: Terminated
Brands named
medtronic advanced energymedtronicmedtronic advanced
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCHonlyne LED Party Favors Recalled Due to Risk of Serious Injury Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries; Sold by Huizhou Rongheng Network Technology2026-06-25
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDAMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDABrand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profo...2026-04-30
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