FDA Device recall Z-2056-2015
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch
- FDA Device
- Class II
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class II recall of Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch by Integra Lifesciences D B A Integra Pain Management, citing integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2056-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-01 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences D B A Integra Pain Management |
| Distribution | US |
Product
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.
Reason
Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).
Identifiers
| code_info | W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2016-09-07 · Integra Lifesciences D B A Integra Pain Management - Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are pla…
FDA Device · Class II · 2015-11-04 · Integra Lifesciences D B A Integra Pain Management - Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalog…
FDA Device · Class II · 2015-05-06 · Integra Lifesciences D B A Integra Pain Management
All Integra Lifesciences D B A Integra Pain Management recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2056-2015%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.