Device recall: Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet…

Class II FDA enforcement event 70873. Recall start date: 30 Mar 2015. Status in the FDA record: Terminated. Termination date: 24 Jun 2015.

Reason for recall, in the words of FDA

A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Integra LifeSciences Corp. d.b.a. Integra Pain Management started this device recall on 30 Mar 2015. The firm address in the FDA record is in Salt Lake City, UT. FDA put the recall in Class II. FDA event 70873 has 1 product record. The first FDA enforcement report date is 6 May 2015. The record gives the status Terminated, with the termination date 24 Jun 2015.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution.

Recalling firm

Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 70873: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1544-2015	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.	90 Tuohy needles (9 cases of 10 each)	Class II	Terminated	6 May 2015

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Integra LifeSciences Corp. d.b.a. Integra Pain Management
Initiated	Product (first record)	Type	Class	Records
24 Aug 2016	PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit con	Device	Class II	1
24 Aug 2016	Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND	Device	Class II	1
4 Aug 2016	INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.	Device	Class II	1
22 Sep 2015	Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marro	Device	Class II	1
1 May 2015	Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibration	Device	Class II	1
26 Nov 2013	Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra„ Cranial Access Kits (CRAK) allows for burr hole acc	Device	Class II	1
28 Oct 2013	Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra k	Device	Class II	1
4 Sep 2013	Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the su	Device	Class II	1
7 Jun 2012	Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile in	Device	Class III	1

Integra LifeSciences Corp. d.b.a. Integra Pain Management: all 10 events

Official channels

FDA enforcement report Z-1544-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 70873. https://recallregister.com/fda/ii/70873/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution.
What quantity of product is in FDA event 70873?: The FDA record gives this quantity: 90 Tuohy needles (9 cases of 10 each)
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.