24 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
FDA Recall
Open, Classified
·Smith & Nephew Inc·Product code JWH·October 2, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
FDA Recall
Open, Classified
·Smith & Nephew Inc·Product code JWH·October 2, 2024
VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LON·June 26, 2025
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
FDA Recall
Open, Classified
·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
FDA Recall
Open, Classified
·Product code KGN·February 10, 2026
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·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, 8x12 cm, and 8x8 cm.
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·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), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
FDA Recall
Open, Classified
·Accriva Diagnostics, Inc.·Product code GGN·April 30, 2026
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 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 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code KGN·March 19, 2026
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm
FDA Recall
Open, Classified
·Collagen Matrix Inc·Product code KGN·August 3, 2022
DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code KGN·May 25, 2022
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).
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code KGN·May 23, 2023