The Recall Desk

Manufacturer

TEI Biosciences, Inc.

17 recalls in our database name TEI Biosciences, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
17
Critical
0
Severe
0
Most recent
2023-07-12

Of the 17 recalls from TEI Biosciences, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–17 of 17

  • HighFDA (Devices)·Z-2079-2023·2023-07-12

    Dermal Repair Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling PriMatrix Meshed dermal repair scaffolds due to endotoxin testing failures. The recall affects 33,277 units distributed nationwide.

    Product
    PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2023·2023-07-12

    Revize Collagen Matrix Recalled for Potential Endotoxin Testing Issues

    TEI Biosciences recalls 199 units of Revize Collagen Matrix due to possible out-of-specification endotoxin test results from faulty testing procedures. The product is distributed nationwide.

    Product
    Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2023·2023-07-12

    SurgiMend 4.0 Collagen Implants Recalled for Endotoxin Testing Failures

    TEI Biosciences is recalling 5,664 units of SurgiMend 4.0 soft tissue reconstruction implants nationwide due to issues with endotoxin testing that may have resulted in out-of-specification test results.

    Product
    SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2023·2023-07-12

    PriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.

    Product
    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2023·2023-07-12

    Surgical collagen matrix recall due to endotoxin testing failures

    TEI Biosciences is recalling 22,163 units of SurgiMend PRS collagen matrices due to endotoxin testing deficiencies that may have resulted in contaminated products being distributed. No injuries have been reported.

    Product
    SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2023·2023-07-12

    SurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.

    Product
    SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2023·2023-07-12

    PriMatrix Ag Dermal Repair Scaffold Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.

    Product
    PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2023·2023-07-12

    SurgiMend 2.0 Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.

    Product
    SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2023·2023-07-12

    SurgiMend soft tissue collagen matrix recalled for endotoxin testing verification issues

    TEI Biosciences recalls 14,535 units of SurgiMend collagen matrices distributed nationwide due to potential endotoxin testing verification problems. Affected devices cannot be confirmed to meet endotoxin specifications.

    Product
    SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2085-2023·2023-07-12

    Soft tissue repair matrix recalled due to possible endotoxin contamination

    TEI Biosciences is recalling 4,832 units of TissueMend Advanced Soft Tissue Repair Matrix due to possible out-of-specification endotoxin test results. No illnesses or injuries have been reported.

    Product
    TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2023·2023-07-12

    Collagen surgical matrix recalled for potential endotoxin testing issues

    TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a surgical collagen matrix, due to possible out-of-specification endotoxin test results.

    Product
    SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2023·2023-07-12

    Dermal repair scaffold recalled due to endotoxin testing failures

    TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.

    Product
    PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2023·2023-07-12

    PriMatrix Ag Fenestrated dermal repair scaffolds recalled for endotoxin testing issues

    TEI Biosciences recalled 7,264 units of PriMatrix Ag Fenestrated dermal repair scaffolds nationwide due to possible out-of-specification endotoxin test results caused by testing methodology defects.

    Product
    PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2023·2023-07-12

    SurgiMend 3.0 Soft Tissue Graft Recalled for Endotoxin Testing Defect

    SurgiMend 3.0 collagen matrix is being recalled nationwide (13,390 units) due to possible endotoxin contamination from deficiencies in endotoxin testing procedures.

    Product
    SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2023·2023-07-12

    PriMatrix Dermal Repair Scaffold recalled due to endotoxin testing issues

    TEI Biosciences is recalling 4,159 units of PriMatrix Dermal Repair Scaffold nationwide due to possible out-of-specification endotoxin test results. Quality control issues during testing led to this recall.

    Product
    PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2023·2023-07-12

    SurgiMend collagen matrices recalled for endotoxin test result quality issues

    TEI Biosciences recalls SurgiMend 1.0 collagen matrices due to problems with endotoxin testing procedures that may have produced inaccurate test results. 52 units were distributed nationwide.

    Product
    SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2023·2023-07-12

    Collagen matrix recalled for endotoxin testing methodology issues

    TEI Biosciences recalled 665 units of Revize-X collagen matrix nationwide due to possible out-of-specification endotoxin test results caused by issues with the company's testing procedures. No illnesses have been reported.

    Product
    Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

TEI Biosciences (United States)

company in Waltham, United States

Country
United States

Source: Wikidata (Q30292175), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.