Z-0503-2018Class II

bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234

Name: Z-0503-2018 bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234
Creator: Beaver-Visitec International Inc.
Published: 2017-11-03
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-11-03 / Terminated / root cause: manufacturing process

FDA source

Beaver-Visitec International Inc. began a recall of bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic... on 2017-11-03. FDA classified it as Class II and gives the reason as "The protective shield was retracted, and the blade was exposed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0503-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2018-02-01
Terminated: 2023-05-31
Recalling firm: Becton Dickinson & Co
Product: bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Product code: EMF Knife, Surgical
Reason for recall: The protective shield was retracted, and the blade was exposed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm disseminated their safety advisory notices on 11/03/2017 by email and visit. The letter identified the affected product, problem and actions to be taken. The firm requested the following action:"Prior to opening the Tyvek tray, please visually confirm that the plastic shield is not retracted and the activation slider is fully engaged."
Quantity in commerce: 123,240 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Product codes and lots: Batch Numbers: 3180336 3181395 3183925 3184461 3183518 3187183 3187940 3189616 3190463 3192521 3193360 3194101 3199801 3200589 3201368 3201959 3202091 3202764 3203228 3204381 3205075 3205511 3205828 3207499 3208102 3211276 3215327 3218819 3218144 3220074 3221091 3221092 3223818 3223055 3223115 3224020 3225234

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0503-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0500-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0501-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0502-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0503-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0504-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01

Product code EMF

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)