Z-0633-2024Class II

Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025

Name: Z-0633-2024 Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025
Creator: Beaver Visitec International, Inc.
Published: 2023-10-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2023-10-10 / Open, Classified

FDA source

Beaver Visitec International, Inc. began a recall of Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025 on 2023-10-10. FDA classified it as Class II and gives the reason as "One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0633-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-10
Posted: 2024-01-04
Recalling firm: Becton Dickinson & Co
Product: Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025
Product code: HNN Knife, Ophthalmic
Reason for recall: One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
FDA root cause: Under Investigation by firm
Action: An "URGENT Field Safety Notice" dated 10/10/23 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. Only destroy the knives in your inventory that have the incorrect bevel orientation (bevel down). If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed. 4. Return the completed BRF and evidence of destruction of affected product to BVI by emailing the attached to [email protected]. BVI values your business and apologizes for the inconvenience this may have caused. Please direct any questions regarding credit to our customer service department by email and include in the subject line: Master Case PIR 00487979. Country Customer Service Email UK [email protected] FR [email protected] DE/ AT [email protected] IT [email protected] ROW [email protected]
Quantity in commerce: 2160 units
Distribution: International Distribution to Japan.
Product codes and lots: UDI-DI: 30886158000373; Lot Number: 6049877

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0633-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0633-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-04

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)