Green Silicone Seal for Accessories, Reusable Silicone Seal… recallZ-2140-2025 · Olympus Corporation of the Americas · initiated Jun 18, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
FDA root cause category: Packaging change control
What the company is doing
Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.
Recall details
- Recall number
- Z-2140-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 18, 2025
- Posted by the FDA
- Jul 21, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 41 units
- Product code
- HIH
- FDA submissions
- K890328
- Distribution
- International distribution to the country of Japan.
Product description
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
Code information (models, lots, serial numbers)
Model Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gyrus ACMI CS-G7Gyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall0 reports
Other devices under the same FDA submission
39 devices cleared under K890328 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- M3 Gold M3-30AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- USA Elite MLE-24-012Gyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- Classic Series C650-129AGyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall4 reports
- Blue Silicone CS-B612Gyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall2 reports
- USA Elite RBGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall1 report
- Gyrus ACMI 194Gyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall0 reports
- USA Elite 190-NRSGyrus ACMI, LLC · Hysteroscope (And Accessories)1 recall0 reports
- M3 Gold M3-70AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall0 reports
- USA Elite EIS-HCF25Gyrus ACMI, LLC · Hysteroscope (And Accessories)25 reports
- M3 Gold REXM3-30AGyrus ACMI, LLC · Hysteroscope (And Accessories)14 reports
- USA Elite EMRS-26BGyrus ACMI, LLC · Hysteroscope (And Accessories)9 reports
- Elite 2 System E2OS-CF25Gyrus ACMI, LLC · Hysteroscope (And Accessories)7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96982).
- Z-2139-2025 · Open, ClassifiedBlue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some…
- Z-2141-2025 · Open, ClassifiedGlass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Z-2142-2025 · Open, ClassifiedTubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths…
- Z-2143-2025 · Open, ClassifiedEllik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Z-2144-2025 · Open, ClassifiedEllik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Z-2145-2025 · Open, ClassifiedEllik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Z-2146-2025 · Open, ClassifiedCone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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