Z-1435-06

MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand

Name: Z-1435-06 MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
Creator: Microvision Medical Holding B.V.
Published: 2006-07-21
License: https://open.fda.gov/license/

Microvision Medical Holding B.V. / initiated 2006-07-21 / Terminated / root cause: packaging

FDA source

Microvision Medical Holding B.V. began a recall of MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand on 2006-07-21. The reason FDA records is "Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1435-06
Status: Terminated
Initiated: 2006-07-21
Posted: 2006-08-23
Terminated: 2006-11-15
Recalling firm: Microvision Medical Holding B.V.
Product: MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVisionMedical brand
Product code: FSO Microscope, Surgical, General & Plastic Surgery
Reason for recall: Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm issued a recall letter dated 7/21/06 to their customers informing them of the problem and the need to return the product.
Quantity in commerce: 540 caps
Distribution: World wide-The product was shipped to physicians in UT, IA, OR, MA, LA, CA. The product was also shipped to Germany, United Kingdom, and The Netherlands.
Product codes and lots: Lot number 583546

Product code FSO

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)