Karl Storz Endoscope Sterilization Trays Instructions for Use Updated
Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.
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: FDA Class II medical device with instructions for use deficiency affecting sterilization procedures. Improper sterilization of medical instruments represents a risk-of-harm scenario without reported illness or injury, consistent with High severity criteria.
Plain-English summary
Karl Storz Endoscopy is recalling instructions for use for Udel Sterilization Trays used in medical facilities. The recall affects approximately 71,892 units distributed across the United States and internationally.
The original instructions for use contained deficiencies that could affect sterilization effectiveness. Specifically, they did not properly exclude ethylene oxide as a sterilization modality and lacked clear compatibility specifications for flexible endoscopes.
The updated instructions (version PI-000078-10.0 from June 2021 and later) now specify that Udel trays may be used with flexible endoscopes having lumen diameters of 1.2 millimeters or greater with a maximum length of 845 millimeters. Ethylene oxide is explicitly excluded as an approved sterilization method.
Healthcare facilities and providers using these sterilization trays should obtain and implement the updated Instructions for Use to ensure proper sterilization of medical instruments.
The recalled product
- Product
- Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID…
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 71,892
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 with Instructions for Use Prior to PI-000078-10.0 (06/21)
Distribution
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