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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71238

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 08, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gyrus Acmi, Incorporated

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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, Rx Only, STERILE EO

Z-1752-2015
Recall number
Z-1752-2015
Initiated
May 08, 2015
Classification
Class II
Status
Terminated
Recalling firm
Gyrus Acmi, Incorporated
Quantity
12,020 boxes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential lack of sterility assurance.

Code information

Lot number: JC929332

Distribution pattern

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

device · product 2 of 2

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

Z-1753-2015
Recall number
Z-1753-2015
Initiated
May 08, 2015
Classification
Class II
Status
Terminated
Recalling firm
Gyrus Acmi, Incorporated
Quantity
22,250 boxes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential lack of sterility assurance.

Code information

Lot Number: JC24165

Distribution pattern

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain