Recall Z-2064-2026
Erbe Medical, LLC · initiated March 31, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Codes / lots: UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014
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.
FDA-determined cause: Component change control
Action taken
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
Details
- Recall number
- Z-2064-2026
- Initiated
- March 31, 2026
- Posted by FDA
- May 1, 2026
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Quantity
- 5,500
- 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.
- Recalling firm
- Erbe Medical, LLC, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2062-2026 Class II | ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF:…Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment… | 03/31/2026Open, Classified |
| Z-2063-2026 Class II | ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO…Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment… | 03/31/2026Open, Classified |