# FDA recall Z-2064-2026

> **Erbe Medical, LLC** · Class II · device recall initiated 2026-03-31.

## Product

ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

## Reason for recall

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

## Distribution

US Nationwide distribution including in 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, NV.

## Key facts

- **Recall number:** Z-2064-2026
- **Recalling firm:** Erbe Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-31
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2064-2026

## Citation

> AI Analytics. FDA recall Z-2064-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2064-2026. Source: US FDA. Licensed CC0.

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