Z-2056-2015Class II

Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet...

Name: Z-2056-2015 Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2015-05-01
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2015-05-01 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid... on 2015-05-01. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2056-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-01
Posted: 2015-07-09
Terminated: 2015-12-04
Recalling firm: Integra Pain Management
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.
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: 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).
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated May 1, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Integra is asking customers to do the following: 1. Review your inventory and determine if you have Tuohy Needle, 20 Gauge X 5 inches (Cat. No. PITRW2050) with an affected Lot Number that is listed on page 2. If so, stop using them immediately and remove them from service. 2. Complete the attached form. If you do not have affected product, check the box: I do not have any product(s) with a Lot Number from the list below. 3. If you do have affected product, check the box: I do have product(s) with a Lot Number from the list below. 4. Complete the other information on the form and return it by email or fax as indicated on the form. Keep a copy of the form for your records. When your form is received, Customer Service will contact you and provide an RMA number and directions to return and replace the affected products. Should you have any questions regarding these instructions, please contact Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-6822.
Quantity in commerce: 123 Tuohy needles
Distribution: Nationwide Distribution
Product codes and lots: W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2056-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2056-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-09

Product code BSP

K854816Class IIEpidural Anesthesia NeedlesReganes, Inc. / cleared 1985-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)