Doyen-Collin Mouth Gag 120MM/ General Instruments — Class III medical device recall Z-1358-2018
Terminated recall by Aesculap Implant Systems LLC, reported 2018-04-18, distributed nationwide. The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering
| Recall number | Z-1358-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2018-02-16 |
| Classified | 2018-04-11 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2020-06-30 |
| Distributed | Nationwide (US) |
Product
Doyen-Collin Mouth Gag 120MM/ General Instruments
Reason for recall
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1358-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.