Z-1918-2010

MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors

Name: Z-1918-2010 MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors
Creator: Mira, Inc.
Published: 2010-04-08
License: https://open.fda.gov/license/

Mira, Inc. / initiated 2010-04-08 / Terminated

FDA source

Mira, Inc. began a recall of MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors on 2010-04-08. The reason FDA records is "Devices distributed without an approved 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1918-2010
Status: Terminated
Initiated: 2010-04-08
Posted: 2010-06-29
Terminated: 2016-08-08
Recalling firm: Mira, Inc.
Product: MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors.
Product code: HPS Unit, Cryophthalmic
Reason for recall: Devices distributed without an approved 510(k)
FDA root cause: PMA
Action: Mira contacted accounts by email between 4/08/10-05/21/10 requesting return of inventory.
Quantity in commerce: 5 units
Distribution: Worldwide Distribution -- USA, including the state of NY and the countries of Israel and Italy.
Product codes and lots: SER# W04643-1 SER# 45-1109 SER# 44-1109 One Unit no Serial Number

Product code HPS

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)