Erbe Medical, LLC: ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

Recall number

Z-2064-2026

Recalling firm

Erbe Medical, LLC

Product

ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222

Status

Open, Classified

Initiated

2026-03-31

Posted

2026-05-01

Terminated

not on file

Reason

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.

Root cause

Component change control

Action

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

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.

Lot, serial or model codes

UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014

510(k) numbers

["K190469"]

PMA numbers

not on file

Product code

OCX

Firm FEI

3020712480

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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