CLASS II ONGOING Device recall · Reported 4 May 2022 · FDA Enforcement Report
TearCare version 1.0 SmartHubs recalled by Sight Sciences
Sight Sciences is recalling TearCare version 1.0 SmartHubs, distributed nationwide in the US. The recall was initiated on 23 Mar 2022 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-1001-2022
- FDA event ID
- 89939
- Recalling firm
- Sight Sciences, Menlo Park, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Mar 2022
- FDA classified
- 25 Apr 2022
- Reported
- 4 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Mar 2022 | Recall initiated by company | |
| 25 Apr 2022 | Classified by FDA | +33 days |
| 4 May 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
TearCare version 1.0 SmartHubs
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Is TearCare version 1.0 SmartHubs recalled?
Yes. Sight Sciences recalled TearCare version 1.0 SmartHubs on 23 Mar 2022. The recall is Class II and its status is Ongoing. Recall number Z-1001-2022.
Why was it recalled?
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.
Which lots are affected?
UDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
Where was it sold?
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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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