The Recall Desk

FDA (Devices) recall action 95432

Integra LifeSciences Corp. recalled 22 products on 2024-11-06

The FDA (Devices) publishes a recall like this one as 22 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 22 pages.

Products
22
Announced
2024-11-06
Critical
0
Units
817,695

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–22 of 22

  • HighFDA (Devices)··2024-11-06

    Integra Recalls Surgical Patties and Strips Due to Endotoxin Levels

    Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.

    Product
    SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials used during manufacturing. The affected devices were distributed worldwide to healthcare facilities.

    Product
    SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin

    Integra LifeSciences is recalling surgical patties and strips (Model 801449) due to higher-than-expected endotoxin levels in raw materials that may have resulted in out-of-specification finished products.

    Product
    SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical patties and strips recalled for endotoxin contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials. The contamination may have resulted in out-of-specification finished products.

    Product
    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 the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material, which may result in out-of-specification endotoxin in finished products.

    Product
    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 the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.

    Product
    SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Out-of-Specification Endotoxin

    Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.

    Product
    SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification finished products. The recall affects 2,056 units distributed worldwide.

    Product
    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 the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Codman Surgical Patties and Strips are being recalled due to higher-than-expected endotoxin levels in raw materials. Approximately 93,782 units were distributed worldwide for use in protecting tissue during surgery.

    Product
    SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801451) worldwide due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination.

    Product
    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 the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling CODMAN Surgical Patties and Strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification endotoxin in finished products.

    Product
    MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Contamination

    Integra LifeSciences recalls 33,478 units of surgical patties and strips due to higher-than-expected endotoxin levels in raw materials that may have contaminated finished products.

    Product
    SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Higher Endotoxin Levels

    Integra LifeSciences is recalling Surgical Patties and Strips (Model 801456) due to higher-than-expected endotoxin levels in raw materials. These surgical devices are used for tissue protection during surgery, including CNS procedures.

    Product
    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 central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Codman Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences has recalled Codman Surgical Patties and Strips (Model 801407) due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification endotoxin in finished products used in brain surgery.

    Product
    SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Codman Surgical Patties Recalled for Endotoxin Contamination

    Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips due to endotoxin contamination in raw material that may result in out-of-spec finished products. The devices protect tissue during surgery, including the brain.

    Product
    SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.

    Product
    SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801452) due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination. Approximately 4,818 units are affected.

    Product
    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 the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels in raw materials

    Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical patties recalled due to higher-than-expected endotoxin levels

    Integra LifeSciences Corp. is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may have resulted in out-of-specification finished products used during surgery.

    Product
    SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.

    Product
    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 central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips recalled for endotoxin contamination in raw materials

    Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.

    Product
    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 the central nervous system, during surgery.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.

    Product
    SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Distribution
    2 states