ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
Aniara Diagnostica
Class I - Dangerous
Residual crystallization of the microplate and recurrent negative controls out of range.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
Becton Dickinson &
Class I - Dangerous
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
Becton Dickinson & Company
Class I - Dangerous
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Siemens Healthcare Diagnostics
Class I - Dangerous
There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
Kit BD Max MRSA XT; Catalog # 443461
Becton Dickinson &
Class I - Dangerous
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Edwards Lifesciences
Class I - Dangerous
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Class I - Dangerous
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Class I - Dangerous
Cleaning processes potentially being ineffective
Class I - Dangerous
Cleaning processes potentially being ineffective
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Class I - Dangerous
Cleaning processes potentially being ineffective
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.