485 results
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Sources: EU EUDAMED, US FDA
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Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code LCO·December 15, 2025
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
FDA Recall
Open, Classified
·Aniara Diagnostica LLC·Product code LCO·April 1, 2026
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
FDA Recall
Open, Classified
·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012
SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code KCO·June 23, 2022
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
FDA Recall
Open, Classified
·Hamilton Co·Product code JQW·January 15, 2021
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).
FDA Recall
Open, Classified
·WAVi Co.·Product code GWQ·December 8, 2023
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTY·November 21, 2022
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632and 231633
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in vitro susceptibility testing.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for yeast identification.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code LON·February 29, 2024
BD COR System Software. Model Number: 444829.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code MAQ·June 23, 2025
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code KZJ·April 7, 2026
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657and 231658
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code LON·February 29, 2024
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100
FDA Recall
Open, Classified
·Wondfo USA Co Ltd·Product code GTY·April 22, 2024
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,
FDA Recall
Open, Classified
·Wondfo USA Co Ltd·Product code GTY·April 22, 2024