Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a breach of the sterile barrier, which poses a risk of infection (risk-of-harm) but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Advanced Energy, LLC is recalling 185 units of Intact Disposable Wands (part of the Intact System), catalog number 900-115. These medical devices are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The recall was initiated because the product sterility was compromised due to a breach of the sterile barrier. This defect affects all lot codes of the specific product configuration.
The affected units were distributed worldwide, including nationwide in the United States and in China, Greece, the Netherlands, Egypt, Turkey, and Switzerland. Healthcare providers and facilities should stop using the affected wands and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm 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…
- Manufacturer
- Medtronic Advanced Energy, LLC
- Affected units
- 185
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medtronic Advanced Energy, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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