Recall Z-3300-2026 ยท HIH Hysteroscope (And Accessories)
Olympus Corporation of the Americas
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
| Date | Sep 25, 2026 (initiated Aug 24, 2026) |
| Status | Open, Classified |
| Reason | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. |
| Root cause | Process control |
| Action | Olympus notified the single Japanese distributor on about 08/24/2026 via emailed "URGENT: FIELD SAFETY NOTICE." Consignees and end users are being instructed to store a copy of the provided correct sterilization parameters with current package insert, use only the corrected sterilization parameters, complete and return the provided reply form, and if units have been further distributed, notify those customers. |
| Quantity | 50 units |
| Distribution | International distribution to the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890328 | ADULT RESECTOSCOPE Circon Video, Feb 6, 1990 |