Symmetry Surgical ULTRA Sterrad Container Recall for Sealant Defect
Symmetry Surgical is recalling 149 ULTRA Sterrad containers because deteriorated or missing base trim sealant may allow contaminants to enter the container 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 (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination without confirmed illness.
Plain-English summary
Symmetry Surgical, Inc. is recalling 149 units of the symmetry surgical ULTRA(R) Sterrad container. The affected products include various REF numbers, such as C131310-SP, C13134-SP, and C13135-SP. These containers are used for sterilization and 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 the sterilization process is complete.
Healthcare facilities and users of these containers should stop using the affected units. The source text does not specify a particular action for consumers beyond the recall notice, but standard protocol for recalled medical devices involves contacting the manufacturer or the FDA for instructions on return or replacement.
The recalled product
- Product
- symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP…
- Manufacturer
- Symmetry Surgical, Inc.
- Hazard
- Affected units
- 149
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.
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