Erbe Medical Recalls ERBEFLO 2 Endoscopy Pump 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 5,500 units of ERBEFLO 2, Endoscopy Pump Tubing/Cap Set due to a connector issue that may cause unintended water flow and aspiration risks.
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, Devices.
What Happened
Erbe Medical, LLC initiated a voluntary recall of devices that provide sterile water/CO2/air to endoscopes. The devices 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, which may lead to water aspiration progressing to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Which Products Are Affected
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222. UDI-DI: 04065655000252. Affected lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014. A total of 5,500 units are affected. Distributed nationwide in the United States, including 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, NV.
What You Should Do
Healthcare providers and facilities should follow the recall instructions provided by the recalling firm for the affected devices.
Why This Matters
The Class II recall involves 5,500 units distributed across the United States with potential to cause serious respiratory complications under certain use conditions.
Source
FDA recall number Z-2064-2026 (report date 20260513).
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 (1,429 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.