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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Alcon Custom Pak Surgical Packs Recalled for Incorrect Latex-Free Labeling

Agency Publication Date: March 6, 2025
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Summary

Alcon Research LLC is recalling 2,511 Alcon Custom Pak surgical procedure packs because they are incorrectly labeled as latex-free. While these custom-designed sterile packs are supposed to contain latex components based on their specifications, an internal label mistakenly includes the symbol for a latex-free product. No injuries or incidents have been reported to date regarding this issue.

Risk

Patients or medical staff with latex sensitivities may experience allergic reactions if they use or come into contact with these packs, unaware that they contain latex. Allergic reactions can range from skin irritation to more severe systemic responses.

What You Should Do

  1. This recall affects Alcon Custom Pak surgical packs with the non-latex symbol, identified by various Pak numbers, Lot numbers, and expiration dates. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled surgical packs immediately.
  3. Contact Alcon Research LLC or your authorized distributor to arrange for the return, replacement, or correction of the affected products.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit their website at www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Alcon Custom Pak with Non-Latex Symbol
Model / REF:
12771-18
18050-10
18252-17
12698-09
15632-10
3141-45
12630-07
18925-05
19265-05
13894-16
17550-08
12236-18
11854-15
8043-29
12466-17
15599-17
14764-09
13194-16
17069-09
Lot Numbers:
12771-18/JZ5190507 (Exp 3/31/2025)
18050-10/JZ5200922 (Exp 5/31/2025)
18050-10/JZ5202199 (Exp 9/30/2025)
18252-17/JZ5200852 (Exp 5/31/2025)
12698-09/JZ5201264 (Exp 6/30/2025)
15632-10/JZ5202447 (Exp 6/30/2025)
15632-10/JZ5202445 (Exp 6/30/2025)
3141-45/JZ5201303 (Exp 7/31/2025)
3141-45/JZ5201305 (Exp 7/31/2025)
12630-07/JZ5201295 (Exp 8/31/2025)
18925-05/JZ5194816 (Exp 9/30/2025)
18925-05/JZ5194818 (Exp 9/30/2025)
18925-05/JZ5196180 (Exp 9/30/2025)
18925-05/JZ5196182 (Exp 9/30/2025)
18925-05/JZ5200323 (Exp 11/30/2025)
19265-05/JZ5201146 (Exp 9/30/2025)
19265-05/JZ5201148 (Exp 9/30/2025)
19265-05/JZ5202207 (Exp 9/30/2025)
13894-16/JZ5201181 (Exp 9/30/2025)
13894-16/JZ5202143 (Exp 9/30/2025)
17550-08/JZ5198232 (Exp 10/31/2025)
12236-18/JZ5201054 (Exp 11/30/2025)
11854-15/JZ5201561 (Exp 11/30/2025)
8043-29/JZ5202201 (Exp 11/30/2025)
12466-17/JZ5205311 (Exp 12/31/2025)
12466-17/JZ5205313 (Exp 12/31/2025)
12466-17/JZ5205915 (Exp 1/31/2026)
15599-17/JZ5205311 (Exp 12/31/2025)
15599-17/JZ5205313 (Exp 12/31/2025)
15599-17/JZ5205915 (Exp 1/31/2026)
14764-09/JZ5197158 (Exp 2/28/2026)
13194-16/JZ5197142 (Exp 3/31/2026)
17069-09/JZ5201931 (Exp 9/30/2026)
UDI:
H5301ALCON1CPAK10

Custom-designed sterile surgical procedure packs.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96285
Status: Active
Manufacturer: Alcon Research LLC
Sold By: Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 2511
Distributed To: Alaska, Arkansas, Arizona, Florida, Maryland, Minnesota, North Carolina, Nebraska, Ohio, Pennsylvania, Texas, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.