FDA Device recall Z-0897-2015
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1
- FDA Device
- Class II
- completed
- Published 2015-01-07
On 2015-01-07 the FDA classified a Class II recall of Hypodermic Needle Pro¿ Edge" Safety Device 20G x1 by Smiths Medical Asd, citing needle is not captured in the needle safety sheath in specific lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0897-2015 |
| Classification | Class II |
| Status | completed |
| Initiated | 2014-11-21 |
| Published | 2015-01-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
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.
Reason
Needle is not captured in the needle safety sheath in specific lots.
Identifiers
| code_info | Lot Numbers: 2731779, 2763138, 2771516, 2771517 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0897-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.