FDAClass II · Medical device · Recall Z-2062-2026 · Recalled May 13, 2026

ERBEFLO CleverCap CO2 recall — Erbe Medical, LLC

Agency report date: May 13, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: ERBEFLO CleverCap CO2
Company / brand: Erbe Medical
Lot / serial / date codes: REF/UDI-DI/Lots: 20325-239/04065655000375/W4464506, W4464507, W4464512, W4464514, W4464515, W4464516, W4464517, W4465114, W4465115, W4465116, W4465702, W4465709, W4465991, W4466004, W4466266, W4466267, W4466268, W4466269, W4466271, W4466272, W4466273, W4466275, W4466278, W4466279, W4466813, W4466814, W4466815, W4466816, W4467057, W4467058, W4467059, W4467680, W4467681, W4468147, W4468148, W4468273, W4468274, W4468275, WO468776, WO468777, WO468778, WO468779, WO468780, WO469443, WO469444, WO469448, WO469449, WO469450, WO469451, WO469452, WO469933, WO469934, WO469947, WO469948, WO469949, WO469950, WO469951, WO469952, WO470768, WO470774, WO470775, WO470776, WO470777, WO470778, WO470896, WO470897, WO470913, WO470914, WO470915, WO470922, WO471236, WO471237, WO471238, WO471239, WO471240, WO471241, WO471242, WO473987, WO473988, WO473989, WO473991, WO475246, WO475247, WO475248, WO475249; 20325-240/04065655000405/W4466020, W4466021, WO468768, WO468769, WO468770, WO468771, WO469445, WO469446, WO469447, WO469936, WO469937, WO471244, WO471246, WO473170, WO473171, WO473172, WO473173, WO473174, WO473982, WO473983, WO473984, WO473985, WO474409, WO474410, WO474411, WO474412, WO474413, WO474414, WO475243; 20325-206/04065655000436/W4467039, W4467049, W4467678, W4467679, WO468582, WO470769, WO470770, WO470771, WO470772, WO470773, WO471076, WO471077, WO471078, WO471079, WO471390, WO478365, WO478366, WO478367; 20325-207/04065655000689/W4469939, W4469940, W4469941; 20325-248/04065655001006/W4467050, W4467051, W4467055, W4467056, W4467682, WO470898, WO470899, WO470900, WO470901, WO470902, WO470903, WO471252, WO471253, WO471254, WO471255, WO471256; 20325-208/04065655001099/W4467040, W4468271, WO468760
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.

Agency product description and boundaries

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: ERBEFLO CleverCap CO2 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2062-2026
Brand: All Erbe Medical recalls
Classification: Class II
Units affected: 260,962
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

ERBEFLO CleverCap CO2 recall status

Companies & origin

Recalling firm location: Tempe, AZ, United States
Firm address: 405 W Geneva Dr, 85282-2003

Identifying details (verbatim from the notice)

Product codes / lots: REF/UDI-DI/Lots: 20325-239/04065655000375/W4464506, W4464507, W4464512, W4464514, W4464515, W4464516, W4464517, W4465114, W4465115, W4465116, W4465702, W4465709, W4465991, W4466004, W4466266, W4466267, W4466268, W4466269, W4466271, W4466272, W4466273, W4466275, W4466278, W4466279, W4466813, W4466814, W4466815, W4466816, W4467057, W4467058, W4467059, W4467680, W4467681, W4468147, W4468148, W4468273, W4468274, W4468275, WO468776, WO468777, WO468778, WO468779, WO468780, WO469443, WO469444, WO469448, WO469449, WO469450, WO469451, WO469452, WO469933, WO469934, WO469947, WO469948, WO469949, WO469950, WO469951, WO469952, WO470768, WO470774, WO470775, WO470776, WO470777, WO470778, WO470896, WO470897, WO470913, WO470914, WO470915, WO470922, WO471236, WO471237, WO471238, WO471239, WO471240, WO471241, WO471242, WO473987, WO473988, WO473989, WO473991, WO475246, WO475247, WO475248, WO475249; 20325-240/04065655000405/W4466020, W4466021, WO468768, WO468769, WO468770, WO468771, WO469445, WO469446, WO469447, WO469936, WO469937, WO471244, WO471246, WO473170, WO473171, WO473172, WO473173, WO473174, WO473982, WO473983, WO473984, WO473985, WO474409, WO474410, WO474411, WO474412, WO474413, WO474414, WO475243; 20325-206/04065655000436/W4467039, W4467049, W4467678, W4467679, WO468582, WO470769, WO470770, WO470771, WO470772, WO470773, WO471076, WO471077, WO471078, WO471079, WO471390, WO478365, WO478366, WO478367; 20325-207/04065655000689/W4469939, W4469940, W4469941; 20325-248/04065655001006/W4467050, W4467051, W4467055, W4467056, W4467682, WO470898, WO470899, WO470900, WO470901, WO470902, WO470903, WO471252, WO471253, WO471254, WO471255, WO471256; 20325-208/04065655001099/W4467040, W4468271, WO468760
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.
FDA event ID: 98674
Recall initiated: March 31, 2026
FDA classified: May 1, 2026
FDA report date: May 13, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 11, 2026 at 6:00 PM UTC.

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