Contamac Solutions, Inc. recalls Contamac
Reason for recall
Contact lens insertion solution may lack sterility.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solutionUDIUDI 00850012123002/
What the firm 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 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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1956-2025
- FDA 510(k) clearance · K181566The device's official FDA premarket clearance record
- FDA device classification · MRCOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.5918The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Contamac Solutions, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm
