Class II — Integra LifeSciences Corp. d.b.a. Integra Pain Management
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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). |
| 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… |
| Quantity | 123 Tuohy needles |
| Distribution | Nationwide Distribution |
| Initiated | 2015-05-01 |
| Classified | 2015-07-09 |
| Terminated | 2015-12-04 |
| Recall number | Z-2056-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. d.b.a. Integra Pain Management (Z-2056-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71147/
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