Symmetry and CODMAN QUAD-LOCK Sterilization Containers Recalled for Sterile Barrier Failure
Symmetry Medical/SSI is recalling QUAD-LOCK Sterilization Containers because they may not maintain an effective sterile barrier. The recall covers 2,991 units distributed worldwide.
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 is classified as FDA Class II, and the hazard involves a failure to maintain a sterile barrier, which poses a risk of harm (infection) even though no injuries have been reported. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Symmetry Medical/SSI is recalling Symmetry and CODMAN brand QUAD-LOCK Sterilization Containers. The recall involves 2,991 units of various sizes and configurations, including perforated and non-perforated bottoms and multiple lid colors. The products were distributed nationwide in the United States, Puerto Rico, and internationally to Italy, Australia, Saudi Arabia, the UK, China, Canada, Germany, New Zealand, Colombia, Korea, and Chile.
The recall was initiated because the Quad-Lock Sterilization Container System may not maintain an effective sterile barrier. This defect could compromise the sterility of the instruments stored within the containers. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare facilities and users should stop using the affected containers and contact Symmetry Medical/SSI for instructions on how to return or replace the products. The recall number is Z-0833-2014.
The recalled product
- Product
- Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100m
- Manufacturer
- Symmetry Medical/SSI
- Hazard
- Affected units
- 2,991
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 lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Symmetry Medical/SSI
See all →- HighSymmetry Medical Recalls Collins Radioparent Sternal Blades Due to Breakage Risk
FDA (Devices) · 2013-05-15
Same hazard · sterile barrier failure
See all →- HighDaig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
FDA (Devices) · 2026-05-20
- ModerateB Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall
FDA (Devices) · 2025-05-14
- HighVial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
- HighMedtronic Clearview Blower Mister Model 22120 recalled for potential unsealed sterile packing
FDA (Devices) · 2024-05-22
- HighExactech Equinoxe Reverse Shoulder Humeral Liner Recall Due to Nonconforming Packaging
FDA (Devices) · 2024-04-10