CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Erbeflo CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes recalled
Erbe Medical is recalling Erbeflo CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201, distributed nationwide in the US. The recall was initiated on 31 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2063-2026
- FDA event ID
- 98674
- Recalling firm
- Erbe Medical, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2026
- FDA classified
- 1 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 31 Mar 2026 | Recall initiated by company | |
| 1 May 2026 | Classified by FDA | +31 days |
| 13 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it 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 lots are affected?
REF/UDI-DI/Lots: 20325-201/04065655000603/W4466253, W4466254, W4466256, W4466257, W4466258, WO471080, WO471081, WO471083, WO471084, WO473975, WO473976, WO477586, WO477587, WO477588, WO477589, WO477590; 20325-203/04065655001211/WO473986
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98674This product is part of a recall event; the main page for the event is Erbeflo CleverCap CO2: Hybrid CO2 Tubing/Cap Set recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Erbeflo CleverCap CO2: Hybrid CO2 Tubing/Cap Set recalled | Erbe Medical | Sterility | Nationwide | |
| CLASS II | Erbeflo 2, Endoscopy Pump Tubing/Cap Set recalled by Erbe Medical | Erbe Medical | Sterility | Nationwide |
More recalls from Erbe Medical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Erbeflo 2, Endoscopy Pump Tubing/Cap Set recalled by Erbe Medical | Erbe Medical | Sterility | Nationwide |
| Device | CLASS II | Erbeflo CleverCap CO2: Hybrid CO2 Tubing/Cap Set recalled | Erbe Medical | Sterility | Nationwide |
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