Karl Storz Uvula Retractors Recalled for Inadequate Reprocessing Validation
Karl Storz Endoscopy is recalling 147 units of the REF 723014 Uvula Retractor due to inadequate reprocessing validation. The manufacturer cannot demonstrate that current sterilization methods ensure proper device sterility.
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: This is a Class II recall without reported illnesses, injuries, or documented failures. The hazard is a quality/documentation issue rather than an observed defect. Per the rubric, without reported harm and with a theoretical hazard, this scores as Moderate.
Plain-English summary
Karl Storz Endoscopy is recalling 147 units of the REF 723014 Uvula Retractor (UDI: 04048551193587), a surgical instrument for veterinary use. All lots are included in this recall.
The recall is due to inadequate validation evidence for reprocessing procedures. The manufacturer has not adequately validated that the provided reprocessing methods ensure proper sterilization of the device. Inadequately sterilized surgical instruments pose a risk of microbial contamination or infection.
The affected units were distributed nationwide across 27 U.S. states and Washington DC, including Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, New York, Ohio, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia.
Veterinary practices that received this device should contact Karl Storz Endoscopy. More information about this recall is available from the FDA using recall number Z-1474-2024.
The recalled product
- Product
- Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- Affected units
- 147
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)
- UDI: 04048551193587/ All Lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Karl Storz Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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