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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90743

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

Open FDA event record

Event summary

Timeline bucket
July 27, 2022
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
GELITA MEDICAL GMBH

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

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

Z-1768-2022
Recall number
Z-1768-2022
Initiated
July 27, 2022
Classification
Class II
Status
Completed
Recalling firm
GELITA MEDICAL GMBH
Quantity
3596 boxes of 50 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

Code information

UDI/DI 00860003109915, Batch Numbers: T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T02395/1, expiration date 07.05.2026; T02394/2, expiration date 07.05.2026

Distribution pattern

US Nationwide distribution in the state of Alabama.