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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93692

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

Open FDA event record

Event summary

Timeline bucket
December 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MICROVENTION 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

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

Z-0868-2024
Recall number
Z-0868-2024
Initiated
December 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
MICROVENTION INC.
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

Code information

Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047

Distribution pattern

U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.