U-SDN 2 Part Ultra Modified Seldinger Needles — Class II medical device recall Z-0355-2016
Terminated recall by Procedure Products, Inc., reported 2015-12-09, distributed in MT, NY. The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire i
| Recall number | Z-0355-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Procedure Products, Inc., Vancouver, WA, United States |
| Recall initiated | 2015-10-27 |
| Classified | 2015-12-01 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-04-01 |
| Distributed | MT, NY |
| Quantity | 1,100 units |
| Lot numbers | 9184-A |
Product
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.
Reason for recall
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
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-0355-2016. 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.