Z-1358-2018Class III

Doyen-Collin Mouth Gag 120MM/ General Instruments

Name: Z-1358-2018 Doyen-Collin Mouth Gag 120MM/ General Instruments
Creator: Aesculap Implant Systems LLC
Published: 2018-02-16
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2018-02-16 / Terminated

FDA source

Aesculap Implant Systems LLC began a recall of Doyen-Collin Mouth Gag 120MM/ General Instruments on 2018-02-16. FDA classified it as Class III and gives the reason as "The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1358-2018
Classification: Class III
Status: Terminated
Initiated: 2018-02-16
Posted: 2018-04-11
Terminated: 2020-06-30
Recalling firm: Aesculap Inc
Product: Doyen-Collin Mouth Gag 120MM/ General Instruments
Product code: KBN Gag, Mouth
Reason for recall: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
FDA root cause: Mixed-up of materials/components
Action: An Urgent Medical Device Recall notification will be sent via Fed-ex overnight to our customers on February 16, 2018. Customers will be required to review the recall notification letter in its entirety and ensure all users in the organization are informed about this recall and the affected products
Distribution: nationwide
Product codes and lots: OM040R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1358-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1358-2018	Class III	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-11
Z-1359-2018	Class III	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-11

Product code KBN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)