Recall Z-2794-2026
- Recall number
- Z-2794-2026
- Event number
- 99027
- Firm
- Karl Storz Endoscopy
- Firm FEI
- 3007475226
- Product code
- HIH
- Status
- Open, Classified
- Initiated
- 2026-05-21
- Posted
- 2026-07-23
- Root cause
- Packaging change control
- 510(k) numbers
- K961605, K983901, K173901, K962256, K152143, K982738, K161763, K903146, K961688, K812202, K241987, K171113, K012869, K150158, K013870, K991563, K955119, K160751, K190797, K971518, K071127, K243382, K110038, K201970, K952779, K240978, K182975, K141515, K192811, K945265
Product#
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Reason for Recall#
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.