Astora Recalls MiniArc Pro Sling System Due to Labeling Mismatch
Astora is recalling 52 units of the MiniArc Pro Single incision Sling System because the lot number on the outer carton did not match the labels inside the box.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to a labeling error that affects traceability rather than causing direct physical harm or illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Astora is recalling 52 units of the MiniArc Pro Single incision Sling System, Model number 9000261, Lot 936405xxx. The recall was initiated because the lot number printed on the outer carton label did not match the lot number on the tray label or the identification labels located inside the box.
The identification labels inside the box are intended to be placed on medical records and other documents associated with the procedure. The mismatch in lot numbers may prevent direct traceability of the implanted unit in the future. The affected units were distributed in the states of Arizona, California, Delaware, Illinois, Kansas, Nebraska, New Jersey, New York, Ohio, Pennsylvania, and Texas.
Healthcare providers and patients should contact Astora for further instructions regarding the recall. The source text does not specify a specific action for consumers other than the general recall notification.
The recalled product
- Product
- MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
- Manufacturer
- Astora
- Hazard
- Affected units
- 52
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)
- Lot number 936405. Serial numbers 936405001 through 936405056
Distribution
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