Alcon Custom Pak Medical Device Recall: X-Ray Detectable Sponges
Alcon recalls Custom Pak devices with specific model numbers due to supplier's x-ray detectable sponges. Affected units may pose risks during medical imaging procedures.
Recall notice
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
Contact the company
What happened, in plain English
Alcon is recalling specific Custom Pak devices because they contain x-ray detectable sponges that were part of a supplier recall. This could affect medical imaging safety if the sponges are not properly removed. Read more at govinfonow.com/recall/73160-alcon-custom-pak-medical-device-recall-x-ray-detectable-sponges.
Source Summary by GovInfoNow · govinfonow.com/recall/73160-alcon-custom-pak-medical-device-recall-x-ray-detectable-sponges · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0053-2018
Cite this page
“Alcon Custom Pak Medical Device Recall: X-Ray Detectable Sponges.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73160-alcon-custom-pak-medical-device-recall-x-ray-detectable-sponges. Based on FDA recall #Z-0053-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0053-2018%22&limit=1).
Why it’s dangerous
The recalled sponges are designed to be visible under x-ray, but the supplier's recall indicates a potential issue with their use in medical procedures. If the sponges are not properly removed before x-ray imaging, they could cause complications.
Who’s affected
Patients and medical staff who use the recalled Custom Pak devices during procedures involving x-ray imaging may be at risk. The risk is highest for those using the devices in settings where x-ray imaging is performed.
How to tell if you have this one
Check for model numbers 2033459H, 2034186H, or 2034491H on the Custom Pak device. The recall applies to devices sold by Alcon Research, Ltd.
- Brand
Alcon- Category
Medical device
What to do — step by step
Check Model Numbers
Identify the model number on your Alcon Custom Pak device to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “States in the US - WI, NY, MO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri, New York, Wisconsin.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0053-2018 (August 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0053-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 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.