CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Contamac, Nutrifill Physiologic formula recalled by Contamac Solutions
Contamac Solutions is recalling Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution, distributed nationwide in the US. The recall was initiated on 15 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1956-2025
- FDA event ID
- 96900
- Recalling firm
- Contamac Solutions, Grand Junction, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 May 2025
- FDA classified
- 11 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Device type
- Contact Lenses & Eye Devices
Timeline
| 15 May 2025 | Recall initiated by company | |
| 11 Jun 2025 | Classified by FDA | +27 days |
| 18 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contact lens insertion solution may lack sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaIllinoisIndianaKansasKentuckyLouisianaMaineMichiganNorth CarolinaNew JerseyNew YorkOhioOklahomaOregonPennsylvaniaRhode IslandSouth Carolina
Questions about this recall
Why was it recalled?
Contact lens insertion solution may lack sterility.
Which lots are affected?
UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Contamac Solutions
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Nutrifill Scleral, Hybrid, and Gas Permeable recalled | Contamac Solutions | Foreign Material | Nationwide |
Other Contact Lenses & Eye Devices recalls
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision | CooperVision | Other | Nationwide |
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |