CLASS III Device recall · Reported 18 Apr 2018 · FDA Enforcement Report

Doyen-Collin Mouth Gag/ General Instruments recalled

Aesculap Implant Systems is recalling Doyen-Collin Mouth Gag/ General Instruments, distributed nationwide in the US. The recall was initiated on 16 Feb 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesOM040R

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1358-2018
FDA event ID: 79656
Recalling firm: Aesculap Implant Systems, Center Valley, PA
Classification: Class III
Status: Terminated
Recall initiated: 16 Feb 2018
FDA classified: 11 Apr 2018
Reported: 18 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

16 Feb 2018	Recall initiated by company
11 Apr 2018	Classified by FDA	+54 days
18 Apr 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Doyen-Collin Mouth Gag 120MM/ General Instruments

Where it was distributed

nationwide

Nationwide

Questions about this recall

Why was it recalled?

The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Which lots are affected?

OM040R

Where was it sold?

nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79656

This product is part of a recall event; the main page for the event is Strauss Penis Clamp/General Instruments recalled.

Reported	Class	Recall	Company	Reason	Where
18 Apr 2018	CLASS III	Strauss Penis Clamp/General Instruments recalled	Aesculap Implant Systems	Foreign Material	Nationwide

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