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RecallWatchMedical Device Safety
Class IIOngoingZ-2062-2026

Erbe Medical, LLC recalls ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources

Erbe Medical, LLCTempe, AZ, United StatesReported May 13, 2026 · 2 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources1 code
  • 20325-239
Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR1 code
  • 20325-240
Hybrid CO2 Tubing/Cap Set for Olympus Scopes1 code
  • 20325-206
Hybrid CO2 Tubing/Cap Set for Pentax Scopes1 code
  • 20325-207
ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes1 code
  • 20325-248
Hybrid CO2 Tubing/Cap Set for Fujinon Scopes1 code
  • 20325-208

Lot / code information

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

What the firm is doing

On 3/31/2026, correction notices were emailed to Medical Directors, Risk Managers, Medical Device Safety Officers, or Healthcare Professionals informing them to take the following actions: 1) Discontinue use of unsupported third-party Scope Port Connectors. 2) Provide this notice to all personnel within your organization who use, service, purchase, stock, or otherwise manage. 3) If you further distributed any affected devices, promptly forward this notice to those accounts and request that they take the same actions. 4) Continue following the instructions for use, including verifying connector compatibility, ensuring that all connectors are fully seated, confirming that all joints and interfaces are secure, and verifying correct placement and alignment of the tubing within the pump head. 5) Utilize the compatibility table in the notice until updated Notes on Use is received. 6) Complete and return the response form via email to fieldaction.medical.us@erbegroup.com. Firm contacts: Correction: fieldaction.medical.us@erbegroup.com, 480-564-1899. Routine Customer Service and Complaints: techservices@erbegroup.com, 1-800-778-3723

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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