Aesculap recalls Doyen-Collin Mouth Gag 120MM (OM040R) due to plastic sleeves sticking together after reprocessing, making instruments unusable. Affected users should contact the manufacturer for details.
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Aesculap is recalling Doyen-Collin Mouth Gag 120MM surgical devices because the plastic sleeves can stick together after reprocessing, rendering them unusable. This issue affects medical devices used in procedures requiring safe instrument handling.
The plastic sleeves of the Mouth Gag and Penis Clamp can stick together during or after reprocessing. This makes the instruments unusable for their intended medical purpose, potentially leading to procedural delays or complications.
Healthcare professionals using the Doyen-Collin Mouth Gag 120MM for surgical procedures are most at risk. Patients using these devices during surgery may be affected if the instruments become unusable.
The recalled product is the Doyen-Collin Mouth Gag 120MM (model OM040R) manufactured by Aesculap Implant Systems LLC. It was sold under the brand name Doyen-Collin or General Instruments.
Identify if your device is the Doyen-Collin Mouth Gag 120MM (model OM040R) by checking the product name and model number.
The plastic sleeves of the Mouth Gag and Penis Clamp may stick together during or after reprocessing, rendering the instruments unusable.
The recalled product is the Doyen-Collin Mouth Gag 120MM (model OM040R) manufactured by Aesculap Implant Systems LLC.
The recall record does not specify a remedy, so contact Aesculap Implant Systems LLC directly for further instructions.
We’ve drafted a message you can send Aescul: Aesculap Implant Systems LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-1358-2018 — Aescul: Aesculap Implant Systems LLC Aescul: Aesculap Implant Systems LLC Hello, I own a Aescul: Aesculap Implant Systems LLC that is covered by recall Z-1358-2018 from Aescul: Aesculap Implant Systems LLC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
