FDA Medical Device Recalls (openFDA)
Safety Syringes Inc: UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
- Recall number
- Z-0444-03
- Recalling firm
- Safety Syringes Inc
- Product
- UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
- Status
- Terminated
- Initiated
- 2002-09-05
- Posted
- 2003-01-14
- Terminated
- 2003-12-03
- Reason
- Package integrity not validated. Sterility not assured.
- Root cause
- Other
- Action
- Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.
- Quantity
- 3300
- Distribution
- Medical offices located in California.
- Lot, serial or model codes
- Lot T20201501
- 510(k) numbers
- ["K013801"]
- PMA numbers
- not on file
- Product code
- MEG
- Firm FEI
- 1000220943
- Firm city
- Carlsbad
- Firm state
- CA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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