Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 155 units distributed worldwide.
What this means for you
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 involves a medical device where sterility is compromised, posing a risk of infection. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.
Plain-English summary
Medtronic Advanced Energy, LLC is recalling 155 units of Intact Disposable Wands (part of the Intact System), catalog number 900-112. These 12mm 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 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. The affected units were distributed worldwide, including in the United States, China, Greece, the Netherlands, Egypt, Turkey, and Switzerland. The recall applies to all lot codes.
Healthcare providers and patients who have used or possess these wands should contact Medtronic Advanced Energy, LLC for further instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm 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 br
- Manufacturer
- Medtronic Advanced Energy, LLC
- Affected units
- 155
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
Same manufacturer · Medtronic Advanced Energy, LLC
See all →- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
- SevereMedtronic Intact Disposable Wands Recalled Due to Sterility Compromise
FDA (Devices) · 2017-02-08
- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
Same hazard · infection
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19