Erbe Medical Recalls ERBEFLO CleverCap Hybrid Tubing Sets
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Medical Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,659 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.