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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95581

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

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Event summary

Timeline bucket
October 15, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
OrganOx Ltd

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

OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.

Z-0501-2025
Recall number
Z-0501-2025
Initiated
October 15, 2024
Classification
Class II
Status
Ongoing
Recalling firm
OrganOx Ltd
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

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

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

Code information

UDI-DI: 05060462240029 Serial numbers 511, 512, 514, 515, 516, 517, 518, 519, 520, 522, 523, 524, 525, 527, 528, 529, 530, 531, 533, 535, 536, 537

Distribution pattern

California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.