Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage
Karl Storz is recalling 9,432 units of sterile electrode accessories because damaged packaging may allow 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 Electrode, Roller, Vaporization, 24FR (27050RK/6) and other resectoscope accessories. The recall is due to possible damage to the sterile packaging (blister tray) of these products.
The damaged packaging may result in airborne contamination of the sterile medical devices. The affected products were distributed nationwide in the United States and in Canada.
Healthcare providers and consumers should stop using these products and contact Karl Storz Endoscopy America Inc for further instructions.
The recalled product
- Product
- Electrode, Roller, Vaporization, 24FR (27050RK/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 36835
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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