Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used… — Class II medical device recall Z-0409-2022
Ongoing recall by Beaver Visitec International, Inc., reported 2021-12-29, distributed in CA, CO, LA, MA, MD, ND, PA, TN…. Kit packaging may have small holes compromising product sterility
| Recall number | Z-0409-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beaver Visitec International, Inc., Waltham, MA, United States |
| Recall initiated | 2021-11-17 |
| Classified | 2021-12-21 |
| Reported by FDA | 2021-12-29 |
| Distributed | CA, CO, LA, MA, MD, ND, PA, TN, UT |
| Quantity | 680 units |
| Reason classes | sterility |
| Lot numbers | 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639 |
| Model numbers | MMK884 |
Product
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Reason for recall
Kit packaging may have small holes compromising product sterility
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-0409-2022. 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.