Data Foundry

Medical device recalls 2023

Beaver EdgeAhead Stiletto/MVR Knife — Class II medical device recall Z-0782-2023

Ongoing recall by Beaver Visitec International, Inc., reported 2023-01-11, distributed nationwide. Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead

Recall numberZ-0782-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBeaver Visitec International, Inc., Waltham, MA, United States
Recall initiated2022-11-30
Classified2023-01-04
Reported by FDA2023-01-11
DistributedNationwide (US)
Reason classessterility
UPC / GTIN / UDI-DI00886158100010
Lot numbers3391035, 6053035, 6054175
Model numbers376630, 584896, 6053035, 6054175

Product

Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630

Reason for recall

Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

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-0782-2023. 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.