Aesculap recalls Strauss Penis Clamp 130MM/General Instruments due to plastic sleeves sticking during reprocessing, making instruments unusable after reprocessing. Affected units include model EF401R.
“Aesculap Strauss Penis Clamp 130MM Recall: Reprocessing Causes Unusable Plastic Sleeves.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71939-aesculap-strauss-penis-clamp-130mm-recall-reprocessing-causes-unusable-plastic. Based on FDA recall #Z-1359-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1359-2018%22&limit=1).
Aesculap Implant Systems LLC recalled the Strauss Penis Clamp on Feb. 16, 2018, according to the FDA. The plastic sleeves may stick together during reprocessing, rendering the instruments unusable.
How to tell if you have it
Strauss Penis Clamp 130MM/General Instruments
EF401R
The hazard
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Context
GovInfoNow's records show Aesculap Implant Systems LLC has 26 other recalls on record since Aug. 10, 2017. Other recent recalls of similar products include Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025), Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025) and Merit Medical Allwell Angioplasty Pack Recall (Dec. 4, 2025).
How to tell if you have this one
The recalled product is the Strauss Penis Clamp 130MM/General Instruments with model number EF401R. This was sold by Aesculap Implant Systems LLC.
Brand
Aescul: Aesculap Implant Systems LLC
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
nationwide
Recall number
Product, codes & lots
Quantity
Z-1358-2018
Doyen-Collin Mouth Gag 120MM/ General Instruments; OM040R
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1359-2018 (February 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1359-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.