Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 25, 2015
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Astora recalled MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 9… - a moderate-severity action.
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 9… was recalled by Astora in November 25, 2015. Reason: The lot number on the outer carton label did not match the lot number printed on the tray label or identifica…. Check the official notice for the remedy. Verify recall #Z-0279-2016 with the FDA Devices before acting.
The recall
Astora issued this moderate-severity FDA Devices recall-The lot number on the outer carton label did not match the lot number printed on the tray label or identifica….
- Moderate
- severity level
- 52 units
- affected scope
- Class II
- classification
- November 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0279-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0279-2016) was formally reported on November 25, 2015, with the manufacturer initiating the action on October 26, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Astora is listed as the recalling firm, operating out of Eden Prairie, MN. Federal records list the affected scope as 52.
The documented reason for this recall is: The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other … Distribution data in the federal record shows the product reached: Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX. 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
52
Related Recalls
6
3 from same agency
Product description
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Reason for recall
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0279-2016 |
| Date reported | November 25, 2015 |
| Date initiated | October 26, 2015 |
| Recalling firm | Astora |
| Firm location | Eden Prairie, MN |
| Affected scope | 52 |
| Distribution | Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX |
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-0279-2016) 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? ▼
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.. Recalled by Astora. Units affected: 52.
Why was this product recalled? ▼
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0279-2016.
Where was the recalled product distributed? ▼
Distribution: Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0279-2016) 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 November 25, 2015. 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.