The Recall Desk

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management

10 recalls in our database name Integra LifeSciences Corp. d.b.a. Integra Pain Management as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2016-09-28

Of the 10 recalls from Integra LifeSciences Corp. d.b.a. Integra Pain Management we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

  • ModerateFDA (Devices)·Z-2868-2016·2016-09-28

    Integra Recalls Spinal Tray Kits Missing Needle Introducer

    Integra LifeSciences is recalling 320 packages of Spinal Tray 24G Gertie Marx kits because one lot was shipped without the required needle introducer.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2733-2016·2016-09-14

    Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise

    Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.

    Product
    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2016·2016-09-07

    Integra Recalls Spinal Trays Due to Lidocaine Component Issue

    Integra LifeSciences is recalling specific lots of Spinal Trays because they contain affected Hospira 5% Lidocaine HCL.

    Product
    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0193-2016·2015-11-04

    Integra Bone Marrow Biopsy Trays Recalled Due to Lidocaine Particulate

    Integra is recalling Bone Marrow Biopsy Trays because they contain Hospira Lidocaine vials with visible particulate matter.

    Product
    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 d
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2056-2015·2015-07-15

    Integra Recalls Tuohy Needles Due to Incorrect Gauge and Length Labeling

    Integra LifeSciences is voluntarily recalling 123 Tuohy needles because they were incorrectly labeled as 18 gauge, 3.5 inch instead of 20 gauge, 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1544-2015·2015-05-06

    Integra Tuohy Needles Recalled for Incorrect Length Labeling

    Integra LifeSciences is recalling 90 Tuohy needles that were incorrectly labeled as 5 inches when they are actually 3.5 inches.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2014·2014-01-01

    Integra Recalls Cranial Access Kits Due to Labeling Discrepancies

    Integra LifeSciences is voluntarily recalling unexpired lots of HITHSP10 Cranial Access Kits because the labeling for included DuraPrep and Monocryl sutures does not align with the kit's intended use.

    Product
    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 selecte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2014·2013-12-25

    Integra Epidural Anesthesia Kits Recalled Due to Syringe Plunger Defect

    Integra LifeSciences is recalling specific lots of epidural anesthesia kits because the included BD LOR syringe plunger may stall or stick.

    Product
    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 u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2260-2013·2013-09-25

    Integra Recalls Cranial Access Kits Due to Potential Sterile Seal Compromise

    Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.

    Product
    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 patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1943-2012·2012-07-11

    Integra Recalls Single Shot Epidural Trays Missing Injectable Components

    Integra LifeSciences is recalling one lot of Single Shot Epidural Trays because they were shipped without required injectable components.

    Product
    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 pro
    Category
    Medical Device
    Distribution
    Distributed nationwide