319 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRESOURCE LACERATION TRAY
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code OJV·September 15, 2025
LACERATION TRAY
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code OJV·September 17, 2025
GYN DISPOSABLES TENACULUM 356T (COMPONENT OF GYN DISPOSABLES 935K IUD INSERTION
FDA Adverse Event
Malfunction
·GYN DISPOSABLES·Product code OJV·September 21, 2012
SINGLE USE INSTRUMENT TRAY
FDA Adverse Event
Malfunction
·Product code OJV·November 30, 2022
ONESTEP
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code OJV·March 9, 2026
SPECTRANETICS BRIDGE BALLOON PREP KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS INC·Product code OJV·March 1, 2018
Single Use Instrument Tray
FDA classification
FDA Class 1
·Single Use Instrument Tray
Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 22ga x 1-1/2" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 2 - 1% Lidocaine (5mL); 1 - " x 3" Bandage; 1 - Towel; 1 - CSR Wrap; 1 - Lidocaine Insert; 1 - Ruler with Protractor; 1 - 4" x 4" Sponges in stacks of 5***Catalog Number: CG00552***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - " x 3" Bandage; 2 - Towel; 1 - Fenestrated Drape; 2 - 15mL Specimen Tube; 2 - Specimen Label; 1 - Ruler; 1 - CSR Wrap***Catalog Number: GUTS1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Towel; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 " Safety Needle; 1 21ga x 1-1/2" Safety Needle; 1 25ga x 5/8" Safety Needle; 1 - 10cc Syringe L/L; 2 - 20cc Syringe L/L; 3 - 4" x 4" Sponges in stacks of 5; 2 - 3" x 3" Sponges in stacks of 5; 1 - CSR Wrap; 2 - Fenestrated Drape; 1 - 5" Hemostat Straight Mosquito; 1 - #11 Retractable Scalpel; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - Probe Guide; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Obturator; 2 - Petri Dish***Catalog Number: CB00541TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - #11 Mini Scalpel; 10 - Micro Slides - Frosted end; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - Stirring Rod; 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - CSR Wrap ***Catalog Number: BMT1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 10 - Micro Slides - Frosted end; 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - Stirring Rod; 1 - CSR Wrap***Catalog Number: BMT1601***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 20, 2017
Manifold Kit. Catalog Number K09-11867AP
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016
Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 1 - 10cc Syringe L/L; 3 - 20cc Syringe L/L; 1 - Probe Guide; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 3 - 4" x 4" Sponges in stacks of 5; 1 - Towel; 1 - 2" x 3" ADH Dressing; 1 - Specimen Label; 1 - Obturator; 1 - Male Luer Cap; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0387TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 1cc Syringe L/L; 1 - 5cc Syringe L/L; 2 - 10cc Syringe L/L; 1 Needle Safety Foam Block, Large; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4" x 4" Sponges in stacks of 5; 1 - 2"x 3" ADH Dressing; 1 - Towel; 4 Alcohol Swab Sticks; 20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4 Bone Marrow Needle J Type; 1 - Probe Guide; 1 Obturator.***Catalog Number: CB0318TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Angiotech***Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center*** 1 - 18ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 22ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 2 - 10cc Syringe L/S; 1 - Obturator; 1 - Male Luer Cap; 20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 4 - Ampule Breaker; 2 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Long Handle Scalpel; 4 - 3" x 3" Sponges in stacks of 5 (4-Ply); 4 -Alcohol Swab Sticks; 4 - 1% Lidocaine (5mL); 1 - 2"x3" ADH Dressing; 3 - Towels; 1 - Probe Guide; 1 - Fenestrated Drape; 1 - CSR Wrap; 1 - 19ga x 1-1/2" Filter Needle ***Catalog Number: CB0033TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010
Fluid Management Set. Catalog Number K08-MP5159A
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code OJV·September 23, 2016
Angiotech*** Custom Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Probe Guide; 1 Obturator; 1 - Male Luer Cap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x 3" ADH Dressing; 1 - Towel; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0355TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010