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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98354

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

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Event summary

Timeline bucket
January 13, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Perfusion Systems

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

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Z-1473-2026
Recall number
Z-1473-2026
Initiated
January 13, 2026
Classification
Class II
Status
Ongoing
Quantity
939 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
assembly issue

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

During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

Code information

UDI-DI: 00763000543693; Lot Number: 0232837110, Additional lots as of 5/22/26: 0231547054 0231591827 0231758880 0231758898 0231758932 0231792414 0231792421 0231912903 0232670901 0232709219 0232709254 0232744928 0232784925 0232784989 0232805458

Distribution pattern

US Nationwide. Global Distribution.

Field note

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