Z-1200-2023Class II

CustomEyes kits

Name: Z-1200-2023 CustomEyes kits
Creator: Beaver Visitec International, Inc.
Published: 2022-12-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-12-20 / Open, Classified / root cause: manufacturing process

FDA source

Beaver Visitec International, Inc. began a recall of CustomEyes kits on 2022-12-20. FDA classified it as Class II and gives the reason as "Device packaging may contain open seals, compromising product sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1200-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-20
Posted: 2023-03-01
Recalling firm: Becton Dickinson & Co
Product: CustomEyes kits
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Device packaging may contain open seals, compromising product sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to [email protected].
Quantity in commerce: 4640 units in total
Distribution: US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
Product codes and lots: Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1200-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1199-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01
Z-1200-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01

Product code KDD

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)