Integra Long Epidural Steroid Injection Needle (Tuohy… recallZ-1544-2015 · Integra LifeSciences Corp. d.b.a. Integra Pain Management · initiated Mar 30, 2015
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. d.b.a. Integra Pain Management or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
FDA root cause category: Employee error
What the company is doing
US Consignees were notified by an Urgent: Voluntary Medical Device Recall letter on 3/30/15 delivered by traceable courier service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review their inventory, identify affected products, and immediately stop use and remove them from service. Customers are to complete the attached form and return via mail or fax. Upon receipt of the form, Customer Service will provide an RMA number and directions for returning the affected products to the firm. Customers should contact Customer Service at 1-800-241-2210 with any questions regarding the instructions.
Recall details
- Recall number
- Z-1544-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 30, 2015
- Posted by the FDA
- Apr 29, 2015
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Quantity
- 90 Tuohy needles (9 cases of 10 each)
- Product code
- BSP
- FDA submissions
- K854816
- Distribution
- Nationwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
Lot No. W1412086, Exp DEC-2017.
Other devices under the same FDA submission
1 device cleared under K854816 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medline Industries, Inc. PAIN8045Medline Industries, Inc. · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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