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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76101

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

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Event summary

Timeline bucket
April 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mesa Laboratories 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

ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.

Z-1104-2017
Recall number
Z-1104-2017
Initiated
April 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
Mesa Laboratories Inc
Quantity
328/ 50-count/ boxes; 16,400 individual units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product resistance has fallen outside of label claim within expiry.

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 resistance has fallen outside of label claim within expiry.

Code information

Lot # 637, exp. date 12/2016

Distribution pattern

Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.