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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98145

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

Open FDA event record

Event summary

Timeline bucket
November 03, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GVS TM, 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

SQ40S Blood Transfusion Filter

Z-1157-2026
Recall number
Z-1157-2026
Initiated
November 03, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GVS TM, Inc
Quantity
2,720 filters

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility assurance cannot be confirmed

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

Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

Code information

Product Number: SQ40S UDI-DI code: 10887691000666 Lot Number: 7536142

Distribution pattern

U.S.: ID, NV, SC, MO, TX, CO, MD, CA, VA, DC, PA, IL, OH, AZ, FL, OK, MN, KY, OR, NE, NC, LA, MS, MI, NY, GA, AL, MA