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Integra LifeSciences Corp.

Integra LifeSciences Corp. Recalls

All product recalls associated with Integra LifeSciences Corp..

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Recall Summary

Total Recalls

710

Past Year

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 121–140 of 710 recalls

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Combo Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

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FDA

Jan 19, 2024

Nationwide

• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

FDAJan 19, 2024Nationwide• Integra LifeSciences Corp.

Solgar Glucosamine Chondroitin (Nestle) – packaging error (2023)

Nestle Health Science has initiated a recall of Solgar Glucosamine Chondroitin, 120 Tablets, in Glass bottle, 12 bottles per case because of error during packaging in which a A Megasorb B-Complex product was filled into bottles labeled as Glucosamine_Chondroitin MSM.

Class IIILow

FDADec 22, 2023IN, NV, NY +3 more• Nestle Product Technology Center - Nestle Health Science

4Kscore Test (BioReference) – modeling adjustment (2023)

Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.

FDAOct 31, 2023Nationwide• BioReference Health, LLC

CD11b APC (BD Biosciences) – cell staining quality (2023)

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

FDAOct 25, 2023Nationwide• Becton, Dickinson and Company, BD Biosciences

INDICAID COVID-19 Test (Phase Scientific) – incorrect expiration (2023)

COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.

FDAOct 25, 2023Nationwide• PHASE SCIENTIFIC INTERNATIONAL LIMITED 1/f, E Phase 3 Hong Kong Science Park Sha Tin Hong Kong SAR

Oxaydo Tablets (Zyla Life Sciences) – Sub-potent Drug (2023)

Sub-potent Drug: Lower potency than labeled.

Class IIILow

FDAOct 20, 2023Nationwide• Zyla Life Sciences US Inc.

Cranial Access Kit (Integra) – packaging defect (2023)

Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device

FDAOct 19, 2023Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – packaging defect (2023)

Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device

FDAOct 19, 2023Nationwide• Integra LifeSciences Corp.

Combo Kit (Integra) – packaging defect (2023)

Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device

FDAOct 19, 2023Nationwide• Integra LifeSciences Corp.

Para-Pak Zn-PVA (Meridian) – leakage risk (2023)

Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

FDAOct 19, 2023Nationwide• Meridian Bioscience Inc