Z-0066-2008

BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)

Name: Z-0066-2008 BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
Creator: Becton Dickinson and Company
Published: 2007-08-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-08-09 / Terminated / root cause: design

FDA source

Becton Dickinson and Company began a recall of BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD) on 2007-08-09. The reason FDA records is "Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0066-2008
Status: Terminated
Initiated: 2007-08-09
Posted: 2007-10-23
Terminated: 2012-02-29
Recalling firm: Becton Dickinson & Co
Product: BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
Product code: HMY Keratome, Battery-Powered
Reason for recall: Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea
Root cause tag: design
FDA root cause: Component design/selection
Action: BD Medical notified customers by Advisory Letter dated 8/09/07, advising users to return heads and bearing cartridges for replacement of the o-ring.
Quantity in commerce: 256 units
Distribution: Worldwide
Product codes and lots: All serial numbers

Product code HMY

K023092Class IBd K-4000 Microkeratome SystemBecton, Dickinson & CO / cleared 2002-10-18

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)