CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report

Green Silicone Seal for Accessories, Reusable Silicone Seal recalled

Olympus Corporation of the Americas is recalling Green Silicone Seal for Accessories, Reusable Silicone Seal 0. The recall was initiated on 18 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers

Quantity recalled41 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2140-2025
FDA event ID: 96982
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Jun 2025
FDA classified: 21 Jul 2025
Reported: 30 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

18 Jun 2025	Recall initiated by company
21 Jul 2025	Classified by FDA	+33 days
30 Jul 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

International distribution to the country of Japan.

Questions about this recall

Why was it recalled?

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

Which lots are affected?

Model Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers

Where was it sold?

International distribution to the country of Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 96982

This product is part of a recall event; the main page for the event is Ellik Evacuator recalled by Olympus Corporation of the.

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025	CLASS II	Ellik Evacuator recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Sterility	PA
30 Jul 2025	CLASS II	Tubing for Male Connector 194, Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	PA
30 Jul 2025	CLASS II	Cone with Male Tubing, Non-Locking, Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	PA
30 Jul 2025	CLASS II	Glass Body For 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	PA
30 Jul 2025	CLASS II	Ellik Latex Bulb, Ellik Evacuator recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Sterility	PA
30 Jul 2025	CLASS II	Ellik Evacuator Adapter, Locking recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Sterility	PA
30 Jul 2025	CLASS II	Blue Silicone, Reusable Silicone Seal recalled	Olympus Corporation of the Americas	Sterility	PA

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide