Integra LifeSciences Corp.

Complete recall history across all FDA and CPSC categories — 216 total recalls

Integra LifeSciences Corp. 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 (216)

FDA medical device enforcement actions by Integra LifeSciences Corp.. Showing most recent 50.

Date Product Reason Class
Feb 6, 2025 AURORA Surgiscope System, Sterile, single use device that contains a Sheath, ... Possibility for the obturator to break (separate). Class II
Jan 10, 2025 Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... Potential that the induction seal is not completely sealed to the device tube... Class II
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrec... Class II
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8... Potential for certain SKUs and lot numbers were distributed with the incorrec... Class II
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrec... Class II
Sep 26, 2024 Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 Out of specification endotoxin levels. Class II
Sep 20, 2024 SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties a... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CO... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and sur... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgi... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgi... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties ... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and sur... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 20, 2024 SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material u... Class II
Sep 13, 2024 MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/A... There is a potential for pinholes in the applicator pouch film which creates ... Class II
Jul 9, 2024 TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV ... Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly cal... Class II
Jun 7, 2024 AURORA Surgiscope System. Sterile, single use device that contains a Sheath, ... Potential sheath damage that could lead to tissue damage and/or track hemorrh... Class II
May 29, 2024 CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical proce... Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may ... Class II
May 7, 2024 CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to... Defect in the external sterile packaging (pouch) leading to a gap or/and weak... Class II
May 7, 2024 CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for ga... Defect in the external sterile packaging (pouch) leading to a gap or/and weak... Class II
May 7, 2024 CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the vent... Defect in the external sterile packaging (pouch) leading to a gap or/and weak... Class II
Apr 17, 2024 Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used duri... Potential holes and tears in the sterile packaging (header bag) of the Crania... Class II
Jan 19, 2024 Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachno... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit ... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space o... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access t... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid ... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Jan 19, 2024 Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and... A defect in the sterile packaging (header bag) of the Cranial Access Kit fail... Class II
Oct 19, 2023 Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoi... Defect in the outer packaging of the Cranial Access Kits. can cause the packa... Class II
Oct 19, 2023 Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packa... Class II
Oct 19, 2023 Integra Cranial Access Kit- For access to the subarachnoid space or the later... Defect in the outer packaging of the Cranial Access Kits. can cause the packa... Class II

View all 216 device recalls →

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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