Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 13, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
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 f…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Erbe Medical, LLC recalled ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 - a moderate-severity action.
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 was recalled by Erbe Medical, LLC in May 13, 2026. Reason: Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment conn…. Check the official notice for the remedy. Verify recall #Z-2064-2026 with the FDA Devices before acting.
The recall
Erbe Medical, LLC issued this moderate-severity FDA Devices recall-Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment conn….
- Moderate
- severity level
- 6K units
- affected scope
- Class II
- classification
- May 13, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2064-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2064-2026) was formally reported on May 13, 2026, with the manufacturer initiating the action on March 31, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Erbe Medical, LLC is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 5,500.
The documented reason for this recall is: 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 th… Distribution data in the federal record shows the product reached: 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, N…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5,500
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2064-2026 |
| Date reported | May 13, 2026 |
| Date initiated | March 31, 2026 |
| Recalling firm | Erbe Medical, LLC |
| Firm location | Tempe, AZ |
| Affected scope | 5,500 |
| 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, L… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2064-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222. Recalled by Erbe Medical, LLC. Units affected: 5,500.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2026. Severity: Moderate. Recall number: Z-2064-2026.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2064-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 13, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.