Data Foundry

Medical device recalls 2021

REF 4890 SMARTSCRAPER CE0123 — Class II medical device recall Z-1779-2021

Terminated recall by Meta C.G.M. Spa, reported 2021-06-09, distributed in FL, TX. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

Recall numberZ-1779-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMeta C.G.M. Spa, Correggio, Italy
Recall initiated2021-04-26
Classified2021-06-02
Reported by FDA2021-06-09
Terminated2024-09-12
DistributedFL, TX
Quantity27 units
Reason classeslabeling, sterility
Lot numbers1-35319
Model numbers4890

Product

REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.

Reason for recall

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

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-1779-2021. 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.