ERBEFLO CleverCap CO2 Tubing and Cap Sets for Endoscopes
Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing and cap sets used with endoscopes because the distal connector may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk of serious respiratory complications (aspiration pneumonia, acute respiratory distress syndrome, respiratory failure) that could require hospitalization, meeting the Severe threshold.
Plain-English summary
Erbe Medical, LLC is recalling ERBEFLO CleverCap CO2 hybrid CO2 tubing and cap sets designed for use with Olympus, Pentax, and Fujifilm endoscopes. The recalled devices were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from the distal tip under unsupported third-party connector use conditions.
Unintended water flow from the device may lead to water aspiration during endoscopic procedures. Water aspiration may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
The devices were distributed nationwide. Approximately 260,962 units have been recalled across multiple reference numbers and lot codes. Healthcare facilities using these devices should discontinue use and contact Erbe Medical for instructions on replacement or return of affected products.
The recalled product
- Product
- 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…
- Manufacturer
- Erbe Medical, LLC
- Affected units
- 260,962
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by Erbe Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Erbe Medical, LLC
See all →- SevereEndoscopy Pump Tubing/Cap Set water aspiration risk recall
FDA (Devices) · 2026-05-13
- HighERBEFLO CleverCap Endoscope Tubing Sets Recalled for Water Aspiration Risk
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