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Integra LifeSciences Corp. recall records

61 reported ongoing

63 records in this archive. Latest source date Feb 6, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of th...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of th...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of th...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of ...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of ...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the ...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the ...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of t...

Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

Class IIReported ongoing

Distribution: Worldwide Distribution. US Nationwide, Canada Germany United Kingdom of Great Britain and Northern Ireland (the) Malta Italy Barbados Trinidad and Tobago Australia New Zealand N...

Official source
FDA device enforcement

MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)

There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, W...

Official source
FDA device enforcement

TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in...

Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.

Class IIReported ongoing

Distribution: The devices are only sold in the US. The following states have received the product: AL, AZ CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, N...

Official source
FDA device enforcement

CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C26...

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

Class IIReported ongoing

Distribution: Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia (Plurinational State of) Brazil Canada Chile China Costa Rica Dominican Republic (the) El Salvador ...

Official source
FDA device enforcement

CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal ...

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of Ch...

Official source
FDA device enforcement

CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cere...

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of Ch...

Official source
FDA device enforcement

CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices fo...

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of Ch...

Official source
FDA device enforcement

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of CA, BE, CL.

Official source
FDA device enforcement

Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South...

Official source
FDA device enforcement

Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South...

Official source
FDA device enforcement

Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South...

Official source
FDA device enforcement

Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South...

Official source

Reasons in these listed records

  • Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
  • There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
  • Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
  • Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

These examples come from this result page and are not a ranking of every recall reason.

Checking Integra LifeSciences Corp.

Is there a recall on integra lifesciences corp. right now?

This archive contains 63 records, including 61 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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