Aesculap Recalls Doyen-Collin Mouth Gags Due to Sticking Plastic Sleeves
Aesculap Implant Systems LLC is recalling Doyen-Collin Mouth Gags because plastic sleeves may stick together, rendering the instruments unusable.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The defect renders the instrument unusable but does not present a direct safety hazard like injury or contamination.
Plain-English summary
Aesculap Implant Systems LLC is recalling the Doyen-Collin Mouth Gag 120MM/ General Instruments. The recall is due to a defect where the plastic sleeves of the instruments may stick together during or after reprocessing. This issue renders the instruments unusable.
The recall is classified as Class III by the U.S. Food and Drug Administration. The distribution pattern is listed as nationwide. The specific code for the affected product is OM040R.
Healthcare facilities and consumers should stop using the affected instruments. The source text does not provide specific instructions for disposal or return, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Doyen-Collin Mouth Gag 120MM/ General Instruments
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- OM040R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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