FDA Device recall Z-1001-2022
TearCare version 1.0 SmartHubs
- FDA Device
- Class II
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of TearCare version 1.0 SmartHubs by Sight Sciences, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1001-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-23 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sight Sciences |
| Distribution | US |
Product
TearCare version 1.0 SmartHubs
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.
Identifiers
| code_info | UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1001-2022%22
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