Erbe Medical Recalls ERBEFLO CleverCap Hybrid Tubing Sets

Source: FDA · United States

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Erbe Medical, LLC is recalling 23,359 ERBEFLO CleverCap Hybrid Tubing/Cap Sets due to a connector configuration that may cause unintended water flow.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Erbe Medical, LLC initiated a voluntary recall of certain ERBEFLO CleverCap devices after determining they were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from the distal tip under unsupported third-party connector use conditions. This may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

Which Products Are Affected

The recall affects 23,359 units distributed nationwide in the United States, including the states of IL, NY, CA, WA, UT, KY, PA, TX, AL, OH, FL, IN, NJ, NH, MI, CT, AR, MN, WI, AZ, CO, WV, MT, HI, TN, GA, VA, OK, RI, MO, NM, ID, SC, WY, KS, NC, MS, OR, MD, MA, DE, NE, AK, IA, DC, ME, LA, SD, ND, VT, PR, and NV. Affected products include:

  • ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201 (lots: W4466253, W4466254, W4466256, W4466257, W4466258, WO471080, WO471081, WO471083, WO471084, WO473975, WO473976, WO477586, WO477587, WO477588, WO477589, WO477590)
  • ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, 20325-203 (lots: WO473986)

Recall number: Z-2063-2026. Classification: Class II.

What You Should Do

The source data does not specify consumer action steps. Users should refer to the recalling firm for guidance on the devices.

Why This Matters

The recalled devices are used to provide sterile water/CO2/air to endoscopes, and the identified issue may result in serious respiratory complications under certain use conditions.

Source

FDA Enforcement Report, recall number Z-2063-2026 (https://www.fda.gov)

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Erbe Medical, LLC is recalling 23,359 ERBEFLO CleverCap Hybrid Tubing/Cap Sets due to a connector configuration that may cause unintended water flow.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.