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.
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
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- Symmetry Surgical, Inc.
- Hazard
- 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 →Related recalls
Same manufacturer · Symmetry Surgical, Inc.
See all →- HighSymmetry Surgical ULTRA Gravity Sterilizer Containers Recalled for Sealant Defect
FDA (Devices) · 2017-01-18
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FDA (Devices) · 2017-01-18
- HighSymmetry Surgical Disposable Towel Clamp Recalled for Sterility Assurance
FDA (Devices) · 2015-08-05
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