Z-0230-2022Class II

bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as...

Name: Z-0230-2022 bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as...
Creator: Beaver Visitec International, Inc.
Published: 2021-10-08
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2021-10-08 / Open, Classified / root cause: packaging

FDA source

Beaver Visitec International, Inc. began a recall of bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation... on 2021-10-08. FDA classified it as Class II and gives the reason as "Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0230-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-08
Posted: 2021-11-16
Recalling firm: Becton Dickinson & Co
Product: bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
Product code: OJK Eye Tray
Reason for recall: Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: BVI notified Consignees by Urgent Medical Device Recall letter on 10/8/21 via registered mail. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a subrecall. Consider all potential users of this product in your user supply chain. You are encouraged to a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-552-4919 " Email the attached to [email protected] 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3997 If you received this notification without the prepaid UPS label and Business Reply Form (BRF), and require additional shipping labels, or if you have questions regarding the return procedure, please contact Stericycle Inc. at 866-606-8264 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time). Please direct any questions regarding this matter to our customer service department by email [email protected] and please include in the subject line: Master Case PIR 263383
Quantity in commerce: 2 units
Distribution: Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
Product codes and lots: Lot Number 6018382

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0230-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0227-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-16
Z-0228-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-16
Z-0229-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-16
Z-0230-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-16

Product code OJK

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)