FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
- Recall number
- Z-0897-2015
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
- Status
- Completed
- Initiated
- 2014-11-21
- Posted
- 2014-12-30
- Terminated
- not on file
- Reason
- Needle is not captured in the needle safety sheath in specific lots.
- Root cause
- Process control
- Action
- Smith Medical sent on 11/24/2014, consignees an Urgent Field Safety Notice via FedEx Overnight. The notification instructs customers to inspect their inventory and complete and return the attached Urgent Field Safety Notice Confirmation Form to coordinate return of affected product to Smiths Medical for replacement/credit. For questions regarding this information, please contact Smiths Medicals Customer Service Department at 800-258-5361.
- Quantity
- 334,000
- Distribution
- US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
- Lot, serial or model codes
- Lot Numbers: 2731779, 2763138, 2771516, 2771517
- 510(k) numbers
- ["K041399"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- 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