Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns
Gyrus Acmi is recalling 22,250 boxes of Diego Elite Tubesets due to a potential lack of sterility assurance. The devices are used for ENT and head and neck procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 involves a potential lack of sterility assurance in a medical device, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Gyrus Acmi, Incorporated is recalling 22,250 boxes of Gyrus ACMI Diego Elite Tubesets, Catalog No. TS101DC. The recall is due to a potential lack of sterility assurance. The affected lot numbers are JC924165 and below.
These medical devices are intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. The products are labeled as Rx Only and STERILE EO.
The recall covers distribution in the United States, Canada, Australia, Germany, New Zealand, Japan, India, and Great Britain. Healthcare providers and patients should contact Gyrus Acmi for further instructions regarding the affected devices.
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 and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below…
- Manufacturer
- Gyrus Acmi, Incorporated
- Affected units
- 22,250
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: JC24165
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.
See all 2 products in this recall →Related recalls
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