KARL STORZ sterilization trays recalled for inadequate model-specific instructions
FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.
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: This Class II FDA medical device recall involves inadequate sterilization instructions that create a risk-of-harm scenario. Improper use of sterilization trays due to missing model-specific and sterilization-modality guidance could result in devices not being properly sterilized, with potential downstream patient harm. No illnesses or injuries have been reported to date.
Plain-English summary
Karl Storz Endoscopy is recalling 4,386 KARL STORZ Radel Sterilization Trays across eight models (27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A). The trays are plastic containers designed to encase and protect medical devices during the sterilization process. Distribution spans nationwide across all US states and territories, as well as Canada.
The trays are being recalled because their original instructions for use did not provide model-specific guidance and lacked information about appropriate sterilization modalities for each tray model. A new, corrected 510(k) submission now provides instructions specific to each model and includes sterilization modality details.
Without proper model-specific instructions, healthcare facilities may use the trays incorrectly during sterilization, potentially failing to achieve proper device sterilization or risking device damage. This could result in medical devices being used without adequate sterilization. No illnesses or injuries have been reported.
Healthcare facilities using affected trays should contact Karl Storz Endoscopy for the updated, model-specific instructions and verify proper sterilization procedures for each tray model before continued use.
The recalled product
- Product
- KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- inadequate-instructions
- improper-sterilization
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 (8)
- Model - UDI-DI/GTIN: 27717A - 4048551089262
- 27717B - 4048551089286
- 39301A - 4048551156957
- 39301C - 4048551157046
- 39231XA
- 39301C1
- 39311A
- 39317A. All Lots.
Distribution
Distributed nationwide across the United States.
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