Stryker 12-Instrument Sterilization Tray Recalled for Validation Testing Gaps
Stryker Endoscopy is recalling 2,591 12-Instrument Sterilization Trays because gravity sterilization parameters in the reprocessing guide did not fully consider all worst-case scenarios during validation testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a gap in validation testing for sterilization parameters, which is a theoretical risk of inadequate sterilization rather than a reported injury or confirmed contamination event, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 2,591 units of the 12-Instrument Sterilization Tray (Model 0242000012). The product is used to hold and protect surgical instruments during the sterilization process, specifically for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid with perforations to allow sterilizing agents to reach the devices inside, featuring silicon device holders to secure them.
The recall was initiated because the gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing. This issue affects the specific lot and serial numbers listed in the agency's recall record. The product was distributed worldwide.
Healthcare facilities and users should stop using the affected trays and contact Stryker Endoscopy for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible health consequences.
The recalled product
- Product
- 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and li
- Manufacturer
- Stryker Endoscopy
- Affected units
- 2,591
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 (20)
- Model number: 0242000012
- Lot/serial numbers: 021464-2
- 39824-1-1
- 4014
- 643893-1-4
- 27419
- 42901-1-1
- 35728-2-1
- 48639-1-8
- 021464-3
- 40288-1-1
- 43020
- 43893-1-6
- 27701
- 43104-1-1
- 36175-1-1
- 48956-1-1
- 23027
- 40629-3-
- 1
Distribution
Distribution scope not specified by the agency.
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