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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96497

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

Open FDA event record

Event summary

Timeline bucket
October 02, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Edge Biologicals 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

Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

Z-1658-2025
Recall number
Z-1658-2025
Initiated
October 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Edge Biologicals Inc
Quantity
660 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to product outer packaging incorrectly labeled.

Code information

Product Number: T-0780 UDI-DI code: B645T-07803012232023012320240123100E Lot Numbers: 01223

Distribution pattern

U.S. Nationwide distribution in the state of PA.