Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns
Gyrus Acmi is recalling Diego Elite Tubesets due to a potential lack of sterility assurance. The recall affects 12,020 boxes distributed in the US, Canada, and other countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential lack of sterility assurance, which poses a risk of harm (infection) to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Gyrus Acmi, Incorporated is recalling the Gyrus ACMI Diego Elite Tubeset, Catalog No. TS100S. The device is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. The recall involves 12,020 boxes of the product.
The recall is being conducted due to a potential lack of sterility assurance. The affected lot number is JC929332 and below. The product is labeled as sterile and is distributed nationwide in the United States, as well as in Canada, Australia, Germany, New Zealand, Japan, India, and Great Britain.
Healthcare facilities and consumers should stop using the affected product and contact Gyrus Acmi for further instructions. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, R
- Manufacturer
- Gyrus Acmi, Incorporated
- Affected units
- 12,020
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)
- Lot number: JC929332
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Gyrus Acmi, Incorporated 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.
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