The Recall Desk
HighFDA (Devices)·Z-1010-2017·Announced 2017-01-18

Symmetry Surgical ULTRA Steam Container Recall for Sealant Defect

Symmetry Surgical is recalling ULTRA Steam containers because deteriorated or missing base trim sealant may allow contaminants to enter after sterilization.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (contamination of sterilized items) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Symmetry Surgical, Inc. is recalling 7,613 units of the symmetry surgical ULTRA(R) Steam container. The affected reference numbers include C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, and C24136. These products were distributed worldwide.

The recall was initiated because the sealant on the base trim of the sterilizer container may be deteriorated or absent. This defect could provide a path for contaminants to enter the container under certain conditions after sterilization.

The source text does not specify specific actions for consumers or healthcare facilities beyond the recall notice itself.

The recalled product

Product
symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container
Affected units
7,613

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)

  • All

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Symmetry Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →