Karl Storz Cutting Loops Recalled for Potential Sterile Packaging Damage
Karl Storz is recalling specific cutting loops due to possible damage to sterile packaging, which may result in airborne contamination.
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: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 9,432 units of Loop, Cutting, Angled 22FR (26055G/6) resectoscope accessories. The recall is due to possible damage to the sterile packaging (blister tray) of the products.
The damaged packaging may result in airborne contamination. The affected products were distributed nationwide and in Canada. The specific lot number is 36815.
Healthcare providers should check their inventory for this specific product and lot number. If the sterile packaging is damaged, the product should not be used.
The recalled product
- Product
- Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
- Manufacturer
- Karl Storz Endoscopy America Inc
- Affected units
- 9,432
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)
- Lot 36815
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Karl Storz Endoscopy America Inc 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.
See all 12 products in this recall →Related recalls
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