Aesculap Strauss Penis Clamp Recalled Due to Sticking Plastic Sleeves
Aesculap Implant Systems LLC is recalling Strauss Penis Clamps because plastic sleeves may stick together, rendering the instruments unusable.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The defect renders the instrument unusable but does not describe a direct safety hazard like injury or contamination.
Plain-English summary
Aesculap Implant Systems LLC is recalling the Strauss Penis Clamp 130MM/General Instruments. The recall is due to a defect where the plastic sleeves of the instrument may stick together during or after reprocessing. This issue renders the instruments unusable.
The recall is classified as Class III by the U.S. Food and Drug Administration. The distribution pattern is listed as nationwide. The specific code information for the affected units is EF401R.
Healthcare facilities and consumers should stop using the affected instruments. The source text does not specify further instructions for disposal or replacement, but the instruments are described as unusable due to the sticking sleeves.
The recalled product
- Product
- Strauss Penis Clamp 130MM/General Instruments
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
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)
- EF401R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aesculap Implant Systems 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 2 products in this recall →Related recalls
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