American Medical Systems Recalls AdVance Male Sling Systems Due to Packaging Defects
American Medical Systems is recalling AdVance Male Sling Systems because sterile barrier packaging may fail during extreme shipping and handling.
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 and involves a potential loss of sterility due to packaging defects, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
American Medical Systems, Inc. is recalling the AdVance Male Sling System (REF 720088-01) and AdVance XP Male Sling System (REF 720163-01). The recall was initiated after routine periodic packaging testing revealed that the sterile barrier packaging of the Needle Passer components could fail in simulated extreme shipping and handling situations.
The affected products are sterile, single-use surgical instruments consisting of helical needle passers and a mesh sling. The mesh is constructed of polypropylene monofilament and is intended to remain in the body as a permanent implant. The recall covers 10,085 units distributed worldwide, including the United States, Canada, Australia, and numerous countries in Europe, Asia, and South America.
The source text does not specify specific consumer actions or report any illnesses or injuries associated with this recall. The hazard is identified as a potential loss of sterility due to packaging failure under extreme conditions.
The recalled product
- Product
- AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with…
- Manufacturer
- American Medical Systems, Inc.
- Affected units
- 10,085
Distribution
Part of a larger recall action
This product is one of 2 recalled by American Medical Systems, Inc. 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.
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