Sight Sciences, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1001-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

TearCare version 1.0 SmartHubs

Product Classification:

Class II

Date Initiated: March 23, 2022

Date Posted: May 4, 2022

Recall Number: Z-1001-2022

Event ID: 89939

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.

Status: Ongoing

Product Quantity: 921

Code Information:

UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated