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

Complete recall history across all FDA and CPSC categories — 10 total recalls

Integra LifeSciences Corp. d.b.a. Integra Pain Management appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by Integra LifeSciences Corp. d.b.a. Integra Pain Management

Date Product Reason Class
Aug 24, 2016 Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND Integra LifeSciences has been notified of a medical device recall by Adaptive... Class II
Aug 24, 2016 PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide... Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G... Class II
Aug 4, 2016 INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of t... Class II
Sep 22, 2015 Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi... Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% ... Class II
May 1, 2015 Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 ... Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary... Class II
Mar 30, 2015 Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 i... A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged an... Class II
Nov 26, 2013 Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial... Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10... Class II
Oct 28, 2013 Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Numbe... Integra LifeSciences Corporation is recalling certain lots of Integra Kits fo... Class II
Sep 4, 2013 Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INS... Integra is recalling certain lots of Cranial Access Kit due to a possibility ... Class II
Jun 7, 2012 Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit... Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as th... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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