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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67578

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 19, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gyrus Medical, Inc

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

1 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 1

Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).

Z-1196-2014
Recall number
Z-1196-2014
Initiated
February 19, 2014
Classification
Class II
Status
Terminated
Recalling firm
Gyrus Medical, Inc
Quantity
856 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
defective seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the package's sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.

Code information

Lots: MK761655, MK764022, MK767655, MK526401

Distribution pattern

US Distribution.