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TEI Biosciences, Inc. FDA Recalls

17 recalls on file across devices, 0 of them Class I and 17 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
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 cClass IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
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)Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cmClass IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10xClass IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 1Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20xClass IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x1Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.Class IIMay 23, 2023Possible out of specification endotoxin test results due to	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi	Class IIDevices	May 23, 2023

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