🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: March 31, 2026 Erbe Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Erbe Medical, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2062-2026