The Recall Desk
Agency classClass IIOur severity:Severity pendingFDA (Devices)·Z-0167-2027·Announced 2026-10-21

TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.

Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.

The recalled product

Product
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Devices
Affected units
577

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 2026 are impacted.

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · Howmedica Osteonics Corp.

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