TearCare version 1 — Class II medical device recall Z-1001-2022
Ongoing recall by Sight Sciences, Inc., reported 2022-05-04, distributed nationwide. Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant
| Recall number | Z-1001-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sight Sciences, Inc., Menlo Park, CA, United States |
| Recall initiated | 2022-03-23 |
| Classified | 2022-04-25 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 921 |
| UPC / GTIN / UDI-DI | 00858027006273 |
| Lot numbers | 1007076 |
Product
TearCare version 1.0 SmartHubs
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1001-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.