Integra Long Epidural Steroid Injection Needle — Class II medical device recall Z-1544-2015
Terminated recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, reported 2015-05-06, distributed nationwide. A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch nee
| Recall number | Z-1544-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, United States |
| Recall initiated | 2015-03-30 |
| Classified | 2015-04-28 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-06-24 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | DEC-2017, W1412086 |
| Model numbers | PITRW1850 |
Product
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
Reason for recall
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
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-1544-2015. 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.