Z-0782-2023Class II

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

Name: Z-0782-2023 Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract...
Creator: Beaver Visitec International, Inc.
Published: 2022-11-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-11-30 / Open, Classified / root cause: packaging

FDA source

Beaver Visitec International, Inc. began a recall of Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630 on 2022-11-30. FDA classified it as Class II and gives the reason as "Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection". 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-0782-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-30
Posted: 2023-01-04
Recalling firm: Becton Dickinson & Co
Product: Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Product code: HNN Knife, Ophthalmic
Reason for recall: Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Beaver Visitec (BVI) issued Urgent Medical Device Recall Letter (FA-22-006) on 11/30/22 via certified mail to Distributors/Customers. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from the lot that is subject to this recall. 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. Use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product to return. Please return the business reply form to [email protected]. 3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. If you have any questions regarding this Field Action, please contact BVI at 888-708-5723 or [email protected]. If you have affected product, please return product with copy of BRF to: Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Attn: Event 6269 Stericycle 2670 Executive Drive, Suite A, Indianapolis, IN 46241 Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email [email protected] and include in the subject line: Master Case PIR: 387823.
Quantity in commerce: 599 units (US): 410 units; 189 kits
Distribution: US Nationwide distribution.
Product codes and lots: UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0782-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0782-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-04

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