Stryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling
Stryker Endoscopy is recalling 6,388 Arthroscope and Hardware Set Trays because the Instructions for Use incorrectly listed sterilization methods that were not validated at worst-case conditions.
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 2/5 (Moderate).
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 and involves a labeling error regarding sterilization validation. No illnesses or injuries are reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Endoscopy is recalling 6,388 units of the Stryker brand Arthroscope and Hardware Set Tray (Model/Part Number: 233-032-116). The product is a sterilization tray used to hold and protect arthroscopes and arthroscopic hardware devices during the sterilization process. The tray consists of an interlocking tray and lid with perforations to allow the passage of sterilizing agents.
The recall was initiated because the firm's evaluation identified that the original validation for gravity steam, Ethylene Oxide (EO), and STERRAD 100S sterilization methods was not performed at worst-case conditions. As a result, these specific sterilization methods are being removed from the product's Instructions for Use.
The affected units were distributed nationwide in the United States. No specific serial or lot numbers are excluded; the recall applies to all serial/lot numbers for this model. Users should stop using the affected trays for the sterilization methods listed in the recall notice and refer to the updated Instructions for Use provided by the manufacturer.
The recalled product
- Product
- Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the…
- Manufacturer
- Stryker Endoscopy
- Affected units
- 6,388
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 serial/lot numbers
Distribution
Distributed nationwide across the United States.
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