FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination
- Recall number
- Z-2748-2017
- Recalling firm
- Becton Dickinson & Company
- Product
- BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination
- Status
- Terminated
- Initiated
- 2016-09-16
- Posted
- not on file
- Terminated
- 2018-03-20
- Reason
- BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
- Root cause
- Process control
- Action
- BD sent recall letter/return response form on 9/16/2016.
- Quantity
- 29,500 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 6022838 2021-01
- 510(k) numbers
- ["K951254"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- 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
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