FDA Device recall Z-1358-2018
Doyen-Collin Mouth Gag 120MM/ General Instruments
- FDA Device
- Class III
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class III recall of Doyen-Collin Mouth Gag 120MM/ General Instruments by Aesculap Implant Systems, citing the plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1358-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-02-16 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
Product
Doyen-Collin Mouth Gag 120MM/ General Instruments
Reason
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Identifiers
| code_info | OM040R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1358-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.