The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2063-2026·Announced 2026-05-13

ERBEFLO CleverCap Endoscope Tubing Sets Recalled for Water Aspiration Risk

Erbe Medical is recalling ERBEFLO CleverCap hybrid tubing and cap sets for endoscopes due to a connector configuration that may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with a high-risk hazard (water aspiration leading to serious respiratory complications including pneumonia, ARDS, and respiratory failure). The source text does not report any illnesses or injuries, making the hazard currently theoretical, but the potential for serious harm justifies a High severity classification.

Plain-English summary

Erbe Medical, LLC is recalling ERBEFLO CleverCap Hybrid Tubing/Cap Sets for Olympus Scopes (model 20325-201) and Fujifilm Scopes (model 20325-203). The devices provide sterile water, CO2, or air to endoscopes and are used in medical procedures nationwide.

The tubing and cap sets were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from the distal tip when used with unsupported third-party connectors. This design vulnerability may lead to water aspiration during endoscopic procedures.

Water aspiration from these devices may progress to serious respiratory complications including aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure. A total of 23,359 units have been distributed across the United States.

Facilities and healthcare providers who use these products should stop use and contact Erbe Medical, LLC for instructions on obtaining replacement devices or removal of the affected inventory.

The recalled product

Product
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
Manufacturer
Erbe Medical, LLC
Category
Medical Device — Endoscope Accessories
Hazard
Affected units
23,359

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • REF/UDI-DI/Lots: 20325-201/04065655000603/W4466253
  • W4466254
  • W4466256
  • W4466257
  • W4466258
  • WO471080
  • WO471081
  • WO471083
  • WO471084
  • WO473975
  • WO473976
  • WO477586
  • WO477587
  • WO477588
  • WO477589
  • WO477590
  • 20325-203/04065655001211/WO473986

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Erbe Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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