Lower risk Medical device recall · FDA · Published October 15, 2024

Alcon Custom-Pak Products Recall: Tubing Anti-Reflux Valve Breakage Risk

Alcon recalls specific Custom-Pak products with tubing Anti-Reflux Valves that may break due to improper use. Affected units include models from Christiana Care Health Serv, Mercy Hospital, and Illinois Masonic Med Ctr. No remedy is stated in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0490-2025Medical device Alcon ›

Lower-risk recall

Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

Take action

Contact the company

Recalling firmAlcon Research LLC6201 South Fwy · Fort Worth, TX 76134-2099

✎ GovInfoNow plain-language explainer

Alcon is recalling certain Custom-Pak products that contain tubing with an Anti-Reflux Valve (ARV) that has reportedly broken due to improper use. This issue was addressed by updating the product labeling, but no specific action is required for users. Read more at govinfonow.com/recall/53711-alcon-custom-pak-products-recall-tubing-anti-reflux-valve-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/53711-alcon-custom-pak-products-recall-tubing-anti-reflux-valve-breakage · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0490-2025

Cite this page

“Alcon Custom-Pak Products Recall: Tubing Anti-Reflux Valve Breakage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53711-alcon-custom-pak-products-recall-tubing-anti-reflux-valve-breakage. Based on FDA recall #Z-0490-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2025%22&limit=1).

The FDA announced on Oct. 15, 2024, that Alcon Research LLC is recalling surgical kits containing Salem Sump tubing due to reported breakage in the Anti-Reflux Valve caused by improper use. The agency issued recall number Z-0490-2025 for the Class III device.

How to tell if you have it

Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11
Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60
VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61
VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15

The hazard

The FDA reported breakage in the tubing Anti-Reflux Valve (ARV) resulting from improper use. As a consequence of this hazard, changes to labeling were made for the affected products.

Context

GovInfoNow's records show Alcon Research LLC has issued 24 other recalls since July 25, 2018. Recent Alcon recalls include the April 21, 2026 GenTeal Tears Eye Gel recall for lack of sterility assurance and the Nov. 24, 2025 Custom Pak recall for incomplete seals. Other recent recalls of similar products include the May 21, 2026 Bard THORA/ PARA TRAY recall for lidocaine ampoules risk and the June 24, 2026 Covidien V-Loc 90 and V-Loc 180 wound closure device recalls for packaging risks.

How to tell if you have this one

Check for the product model numbers listed in the recall: #15340-11 (Christiana Care Health Serv), #6557-59 and #6557-60 (Mercy Hospital), #9456-59, #9456-60, and #9456-61 (Illinois Masonic Med Ctr), and #12216-12, #12216-14, and #12216-15 (McGee Eye Surg Ctr).

Brand
Alcon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Model
Identify your Custom-Pak model number from the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “US distribution to states of: Delaware, Illinois, and Oklahoma” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Delaware, Illinois, Oklahoma.

Recall timeline

FDA published this recall 43 days after the firm started it.

Oct 15, 2024Firm started the recall
Nov 19, 2024FDA classified it Class III
Nov 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53711-alcon-custom-pak-products-recall-tubing-anti-reflux-valve-breakage">Alcon Custom-Pak Products Recall: Tubing Anti-Reflux Valve Breakage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0490-2025 (October 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0490-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.