Flexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
Karl Storz Endoscopy is recalling 45 Flexible Hystero-Fiberscope Kits that contain expired Single Use Endoscopic Seals, which could compromise sterility assurance during gynecological procedures.
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: This is an FDA Class II recall involving a risk-of-harm medical device where injury has not yet been reported. The expired sterile seal could compromise sterility assurance, posing potential infection risk during gynecological procedures.
Plain-English summary
The U.S. Food and Drug Administration has announced a recall of 45 Flexible Hystero-Fiberscope Kits (REF: 11264BBU1, 11264BBUK1) manufactured by Karl Storz Endoscopy. These kits contain expired Single Use Endoscopic Seals (REF: 26153EAU/1) with an expiration date of January 23, 2023.
The expired sterile seals could impact the assurance of sterility for these medical devices used during diagnostic and operative hysteroscopic procedures. This poses a risk of infection or other complications if the devices are not properly sterile when used on patients.
The affected kits were distributed nationwide in the United States across multiple states including Florida, Massachusetts, Minnesota, Texas, Ohio, New York, California, Michigan, Louisiana, Virginia, Maryland, Pennsylvania, Georgia, Wisconsin, and Vermont. Healthcare facilities and clinics using these devices should immediately stop using them and contact Karl Storz Endoscopy for replacement.
Consumers should not use any affected products. If you have questions about this recall, contact the manufacturer directly or consult the FDA recall notice.
The recalled product
- Product
- Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 45
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 (20)
- Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269
- 2273282
- 2276217
- 2276216
- 2264656
- 2275787
- 2279756
- 2280154
- 2280379
- 2275789
- 2283453
- 2277877
- 2280204
- 2273324
- 2275986
- 2283483
- 2229591
- 2273599
- 2215800
- 2274197
Distribution
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