65 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Human Fetal Hemoglobin (HBF-1) FITC Conjugate
FDA Recall
Terminated
·Life Technologies Corporation·Product code GHQ·February 7, 2018
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JPD·August 18, 2010
VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011
VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code HBF·October 16, 2020
CODMAN Disposable Perforator 9mm. Cranial Perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·September 26, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·April 11, 2025
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·September 26, 2025
Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws).
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code HBF·July 8, 2011
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·April 11, 2025
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product
FDA Recall
Open, Classified
·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DBF·March 5, 2018
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code DBF·October 9, 2012
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
FDA Recall
Terminated
·Sechrist Industries Inc·Product code CBF·August 28, 2008