Z-1952-2015Class III

Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number...

Name: Z-1952-2015 Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number...
Creator: Milestone Scientific, Inc.
Published: 2015-02-11
License: https://open.fda.gov/license/

Milestone Scientific, Inc. / initiated 2015-02-11 / Terminated / root cause: manufacturing process

FDA source

Milestone Scientific, Inc. began a recall of Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe... on 2015-02-11. FDA classified it as Class III and gives the reason as "Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument". 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-1952-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-11
Posted: 2015-07-01
Terminated: 2016-09-20
Recalling firm: Milestone Scientific, Inc.
Product: Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.
Product code: EJI Syringe, Cartridge
Reason for recall: Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Milestone Scientific notified their customers via e-mail and phone on 2/11/2015.
Quantity in commerce: 165,850 units
Distribution: Worldwide distribution. US in FL, IL, NY WA and Puerto Rico, Israel, Croatia, Italy, Australia, Germany, Colombia, UK, Sweden, and UAE.
Product codes and lots: Lot 140103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1952-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1952-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-01

Product code EJI

K061904Class IICompudent StaMilestone Scientific, Inc. / cleared 2006-08-08

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)