Contamac, Nutrifill Physiologic formula, Contact Lens… recallZ-1956-2025 · Contamac Solutions, Inc. · initiated May 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Contamac Solutions, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Contact lens insertion solution may lack sterility.
FDA root cause category: Process control
What the company is doing
On May 15, 2025, Contamac Solutions issued a Urgent Medical Device Recall Notification via Email. In addition, the firm issued a press release concerning the recall on the Contamac Solutions, Inc. eCommerce website . Contamac Solutions ask consignees to take the following actions: 1. Refer to the package label and Product Distribution Information to verify the product is impacted. 2. Immediately quarantine and discontinue use of impacted product 3. Please either return any unused product to Contamac Solutions or destroy and discard the product (i.e. remove vial cap and empty contents before discarding). Please contact [email protected] to initiate a return. 4. Complete the Customer Response form. If you are having trouble accessing the form, please reach out to [email protected] for assistance. 5. Provide the recall notification to all those who need to be aware, including others within your organization or to any organization where the affected devices may have been transferred. 6. Distributors - If you have further distributed the product, please provide this recall notification to those distributors and ask them to provide a copy to their customer.
Recall details
- Recall number
- Z-1956-2025
- Status
- Open, Classified
- Initiated by the company
- May 15, 2025
- Posted by the FDA
- Jun 11, 2025
- Recalling firm
- Contamac Solutions, Inc.
- Quantity
- 17,273 cartons (604,555 ampoules)
- Product code
- MRC
- FDA submissions
- K181566
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, FL, IL, IN, KS, KY, LA, ME, MI, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI.
Product description
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Code information (models, lots, serial numbers)
UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NutrifillContamac Solutions, Inc. · Products, Contact Lens Care, Rigid Gas Permeable1 recall10 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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