Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 17, 2015
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; Rx Only, STERILE EO
Potential lack of sterility assurance.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gyrus Acmi, Incorporated recalled Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, a… - a moderate-severity action.
Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, a… was recalled by Gyrus Acmi, Incorporated in June 17, 2015. Reason: Potential lack of sterility assurance.. Check the official notice for the remedy. Verify recall #Z-1753-2015 with the FDA Devices before acting.
The recall
Gyrus Acmi, Incorporated issued this moderate-severity FDA Devices recall-Potential lack of sterility assurance..
- Moderate
- severity level
- Class II
- classification
- June 17, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1753-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1753-2015) was formally reported on June 17, 2015, with the manufacturer initiating the action on May 8, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Gyrus Acmi, Incorporated is listed as the recalling firm, operating out of Southborough, MA. Federal records list the affected scope as 22,250 boxes.
The documented reason for this recall is: Potential lack of sterility assurance. Distribution data in the federal record shows the product reached: Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
22,250 boxes
Related Recalls
6
3 from same agency
Product description
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; Rx Only, STERILE EO
Reason for recall
Potential lack of sterility assurance.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1753-2015 |
| Date reported | June 17, 2015 |
| Date initiated | May 8, 2015 |
| Recalling firm | Gyrus Acmi, Incorporated |
| Firm location | Southborough, MA |
| Affected scope | 22,250 boxes |
| Distribution | Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1753-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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; Rx Only, STERILE EO. Recalled by Gyrus Acmi, Incorporated. Units affected: 22,250 boxes.
Why was this product recalled? ▼
Potential lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1753-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1753-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 17, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.