Class II — Sight Sciences, Inc.
| Recalling firm | Sight Sciences, Inc. |
|---|---|
| Registered facility | SIGHT SCIENCES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution. |
| Product | TearCare version 1.0 SmartHubs |
| Quantity | 921 |
| Distribution | US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN, MS, RI, WA, IL, FL, NV, NE, VA, SD, KY, OK, NJ, CO, TX, MI, NY, AR, WI, OR, MO, AL, NM, UT, WV, SC, IN, KS, MA, MN, NH, MT, ND, MD, WY, HI, DC, ID, LA, DE. |
| Initiated | 2022-03-23 |
| Classified | 2022-04-25 |
| Recall number | Z-1001-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sight Sciences, Inc. (Z-1001-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89939/
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