FDA (Devices) recall action 96982

Olympus Corporation of the Americas recalled 8 products on 2025-07-30

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2025-07-30
Critical: 0
Units: 143

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

ModerateFDA (Devices)··2025-07-30
Reusable endoscope silicone seals have conflicting sterilization instructions in Japan
Blue Silicone Reusable Silicone Seals 6-12 FR, model CS-B612, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Product
Blue 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 contain a lumen which allows instruments to be passed through the seal and minimize or prevent…
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0 states
ModerateFDA (Devices)··2025-07-30
Ellik Evacuator non-locking cone has conflicting sterilization instructions in Japan
The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model 191-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Product
Cone 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 Sheaths.
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0 states
ModerateFDA (Devices)··2025-07-30
Ellik Evacuator recalled over conflicting sterilization instructions in Japanese inserts
The Ellik Evacuator, model 194, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 11 units are affected.
Product
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
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Distribution
0 states
ModerateFDA (Devices)··2025-07-30
Green endoscope silicone seals have conflicting sterilization instructions in Japan
Green Silicone Seals for Accessories, reusable 0-7 FR, model CS-G7, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Product
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…
Category
Distribution
0 states
ModerateFDA (Devices)··2025-07-30
Ellik Evacuator locking adapter has conflicting sterilization instructions in Japan
The Ellik Evacuator Adapter, Locking, model 190-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 5 units affected.
Product
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
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0 states
ModerateFDA (Devices)··2025-07-30
Ellik Evacuator glass body has conflicting sterilization instructions in Japan
The Glass Body for the 194 Ellik Evacuator, model 190A, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Product
Glass 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.
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Distribution
0 states
ModerateFDA (Devices)··2025-07-30
Ellik Evacuator latex bulb has conflicting sterilization instructions in Japan
The Ellik Latex Bulb, model 194-2, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 48 units affected.
Product
Ellik 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.
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Distribution
0 states
ModerateFDA (Devices)··2025-07-30
Ellik Evacuator male connector tubing has conflicting sterilization instructions in Japan
The Tubing for Male Connector 194, Ellik Evacuator, model 190-4, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Product
Tubing 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.
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0 states