Hypodermic Needle Pro¿ Edge" Safety Device 20G x1 — Class II medical device recall Z-0897-2015
Completed recall by Smiths Medical ASD, Inc., reported 2015-01-07, distributed nationwide. Needle is not captured in the needle safety sheath in specific lots.
| Recall number | Z-0897-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Keene, NH, United States |
| Recall initiated | 2014-11-21 |
| Classified | 2014-12-30 |
| Reported by FDA | 2015-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 334,000 |
| Lot numbers | 2731779, 2763138, 2771516, 2771517 |
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 for recall
Needle is not captured in the needle safety sheath in specific lots.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0897-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.