Integra Pain Management

West Valley City, UT, US

Integra Pain Management appears in FDA device records in West Valley City, UT. FDA records list 3 510(k) clearances between 2011-03-17 and 2012-06-15, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 55 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 55
Registered establishments: 1

FDA records under these names

2 names

FDA records resolved to Integra Pain Management carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Integra Life Sciences510(k), recall
Integra LifeSciences Corp. d.b.a. Integra Pain Managementenforcement report, recall

510(k) clearance history

FDA records hold 3 510(k) clearances for Integra Pain Management between 2011 and 2012. The busiest year on record is 2011, with 2. The most recent is 2012, with 1.

Clearances by year, as a table

510(k) clearance decisions for Integra Pain Management, by decision year
Year	Clearances
2011	2
2012	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K120600	DURAGEN SECURE DURAL REGNERATION MATRIX	GXQ	Substantially Equivalent	2012-06-15
K103248	INTEGRITY SPINAL CARE SYSTEM	ITH	Substantially Equivalent	2011-04-05
K103742	ACCELL EVO3 (FORMERLY ACCELL A2I)	MBP	Substantially Equivalent	2011-03-17

Registered establishments

FDA registered establishments for Integra Pain Management, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1722447	1000138491	Integra Pain Management	3498 WEST 2400 SOUTH, West Valley City, UT 84119 US	2026	BWN EIG GAA GDX GEA GFD GWZ HAW HBG HBL and 9 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

Recall records

Showing 25 of 55

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2868-2016	PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.	Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.	Class II	2016-08-24	Terminated
Z-2733-2016	Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND	Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.	Class II	2016-08-24	Terminated
Z-2684-2016	INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.	Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.	Class II	2016-08-04	Terminated
Z-0193-2016	Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.	Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial.	Class II	2015-09-22	Terminated
Z-2056-2015	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.	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).	Class II	2015-05-01	Terminated
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.	A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.	Class II	2015-03-30	Terminated
Z-0551-2014	Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.	Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.	Class II	2013-11-26	Terminated
Z-0533-2014	Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.	Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.	Class II	2013-10-28	Terminated
Z-2260-2013	Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.	Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.	Class II	2013-09-04	Terminated
Z-1943-2012	Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.	Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.	Class III	2012-06-07	Terminated
Z-0759-2012	Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0758-2012	1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure Monitoring Kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0757-2012	1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP Monitoring Kit, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0756-2012	31144 Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 Micro Ventricular Bolt ICP, 1 CSF Drainage System, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0755-2012	31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0754-2012	1104LC Combo Kit including 1 Camino ICP Monitoring Catheter, 1 Cranial Kit w/Cam Chuck. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0753-2012	Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro, NJ 08536 Contents Sterile and non-sterile, Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0752-2012	Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0751-2012	Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0750-2012	Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0749-2012	Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-0748-2012	1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain including (1) Cranial Kit W/Cam. Chuck, (1) Ventricular Bolt ICP Monitoring Kit, (1) CSF Drainage System. Contains Sterile and Non-Sterile Product. Integra Life Sciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.		2011-12-21	Terminated
Z-2108-2009	Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.	Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.		2009-07-13	Terminated
Z-2107-2009	Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.	Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.		2009-07-13	Terminated
Z-2106-2009	Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.	Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.		2009-07-13	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Integra Pain Management edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain