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FDA Medical Device Recalls (openFDA)

Milestone Scientific, Inc.: 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.

Recall number
Z-1952-2015
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.
Status
Terminated
Initiated
2015-02-11
Posted
2015-07-01
Terminated
2016-09-20
Reason
Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.
Root cause
Nonconforming Material/Component
Action
Milestone Scientific notified their customers via e-mail and phone on 2/11/2015.
Quantity
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.
Lot, serial or model codes
Lot 140103
510(k) numbers
["K061904"]
PMA numbers
not on file
Product code
EJI
Firm FEI
3004082685
Firm city
Livingston
Firm state
NJ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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