Recall Z-2794-2026 ยท HIH Hysteroscope (And Accessories)
Karl Storz Endoscopy
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
| Date | Jul 23, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility. |
| Root cause | Packaging change control |
| Action | On 5/21/2026, correction notices were emailed to customers who were asked to do the following: 1) Check the expiration date for any inventory of 26153EAU-01 Sealing Seal for Gynecology and discard any expired components(seals) by removing the seal from the packaging and discarding the seal and packaging. 2) Pass on this Urgent Medical Device Correction to all users of affected products and all other persons who need to be aware within your organization. 3) If you have or may have distributed the products listed, please identify and promptly notify those recipients with a copy of this notice an |
| Quantity | 45 |
| Distribution | US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961605 | KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE KARL STORZ Endoscopy-America, Inc., Nov 13, 1996 |