Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 8, 2017
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 breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
Medtronic Advanced Energy, LLC recalled Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable P… - a moderate-severity action.
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable P… was recalled by Medtronic Advanced Energy, LLC in February 8, 2017. Reason: Product sterility compromised due to breach of sterile barrier. Check the official notice for the remedy. Verify recall #Z-1130-2017 with the FDA Devices before acting.
The recall
Medtronic Advanced Energy, LLC issued this moderate-severity FDA Devices recall-Product sterility compromised due to breach of sterile barrier.
- Moderate
- severity level
- 185 units
- affected scope
- Class II
- classification
- February 8, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1130-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1130-2017) was formally reported on February 8, 2017, with the manufacturer initiating the action on December 28, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Advanced Energy, LLC is listed as the recalling firm, operating out of Portsmouth, NH. Federal records list the affected scope as 185 units.
The documented reason for this recall is: Product sterility compromised due to breach of sterile barrier Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
185 units
Related Recalls
6
3 from same agency
Product description
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 breast tissue for histologic examination with partial removal of a palpable abnormality.
Reason for recall
Product sterility compromised due to breach of sterile barrier
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1130-2017 |
| Date reported | February 8, 2017 |
| Date initiated | December 28, 2016 |
| Recalling firm | Medtronic Advanced Energy, LLC |
| Firm location | Portsmouth, NH |
| Affected scope | 185 units |
| Distribution | Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1130-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 breast tissue for histologic examination with partial removal of a palpable abnormality.. Recalled by Medtronic Advanced Energy, LLC. Units affected: 185 units.
Why was this product recalled? ▼
Product sterility compromised due to breach of sterile barrier
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2017. Severity: Moderate. Recall number: Z-1130-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1130-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 8, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.