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.
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: 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
Same manufacturer · Karl Storz Endoscopy America Inc
See all →- ModerateKarl Storz Recalls Flexible Intubation Fiberscopes Due to Material Issue
FDA (Devices) · 2013-12-25
- ModerateKarl Storz Recalls Flexible Broncho Fiberscopes Due to Material Issue
FDA (Devices) · 2013-12-25
- ModerateKarl Storz Recalls Misidentified Axillent Debakey Grasping Forceps
FDA (Devices) · 2013-12-18
- ModerateKarl Storz Balloon Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2013-07-24
- ModerateKarl Storz Recalls Roller Ball Electrodes Due to Packaging Damage
FDA (Devices) · 2013-05-22
Same hazard · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02