Z-1894-2011

BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic...

Name: Z-1894-2011 BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic...
Creator: Beaver-Visitec International Inc.
Published: 2011-02-28
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-02-28 / Terminated / root cause: manufacturing process

FDA source

Beaver-Visitec International Inc. began a recall of BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife... on 2011-02-28. The reason FDA records is "Loose blades in the handle of knives due to uncured epoxy". 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-1894-2011
Status: Terminated
Initiated: 2011-02-28
Posted: 2011-04-05
Terminated: 2012-06-14
Recalling firm: Becton Dickinson & Co
Product: BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a variety of ophthalmic surgery. Product is a cataract surgery knife designed for optimal tunnel architecture.
Product code: H--NN
Reason for recall: Loose blades in the handle of knives due to uncured epoxy.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beaver Visitec International, Inc.sent an Urgent Recall Notification letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product and to complete a Customer Response Form (to be returned via fax to 866-906-4304. For questions regarding this recall call 781-906-7917.
Quantity in commerce: 1680 units (1130 domestic, 550 foreign)
Distribution: Worldwide Distribution - USA including AZ, MA, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA and the country of China
Product codes and lots: Lot/serial number: 0333798

Product code H--NN

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)