62 results
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17ms
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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
PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code NGE·May 22, 2023
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
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1505, IV ADMIN SET W/2 H.F. STOPCOCKS; Catalog Number: 490088. 2. IV ADMIN SET W/2 SAFELINE & HF STOPCOCK; Catalog Number: 490107.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FPA·October 29, 2025
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
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
FDA Recall
Open, Classified
·Aesculap Inc·Product code HCF·December 29, 2023
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
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
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
FDA Recall
Terminated
·New Wave Endo-Surgical, Corp.·Product code HCF·July 8, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
FDA Recall
Terminated
·Teleflex Medical·Product code HCF·March 24, 2016
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
FDA Recall
Terminated
·Teleflex Medical·Product code HCF·November 16, 2016
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 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
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Recall
Open, Classified
·Stimwave Technologies Inc·Product code GZF·July 15, 2020
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
FDA Recall
Open, Classified
·Aesculap Inc·Product code HCF·December 29, 2023
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·September 26, 2025
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
FDA Recall
Open, Classified
·Nalu Medical, Inc.·Product code GZF·June 3, 2024