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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73324

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

Open FDA event record

Event summary

Timeline bucket
February 24, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amd Ritmed

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

IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities

Z-1251-2016
Recall number
Z-1251-2016
Initiated
February 24, 2016
Classification
Class II
Status
Terminated
Recalling firm
Amd Ritmed
Quantity
126 cases total (87 cases domestically and 39 cases internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.

Code information

Lot 63927, expiration 2017-04

Distribution pattern

US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.