FDA Medical Device Recalls (openFDA)
Contamac Solutions, Inc.: Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
- Recall number
- Z-1956-2025
- Recalling firm
- Contamac Solutions, Inc.
- Product
- Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
- Status
- Open, Classified
- Initiated
- 2025-05-15
- Posted
- 2025-06-11
- Terminated
- not on file
- Reason
- Contact lens insertion solution may lack sterility.
- Root cause
- Process control
- Action
- 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 recall@contamacsolutions.com to initiate a return. 4. Complete the Customer Response form. If you are having trouble accessing the form, please reach out to recall@contamacsolutions.com 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.
- Quantity
- 17,273 cartons (604,555 ampoules)
- 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.
- Lot, serial or model codes
- UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK
- 510(k) numbers
- ["K181566"]
- PMA numbers
- not on file
- Product code
- MRC
- Firm FEI
- 3016114779
- Firm city
- Grand Junction
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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