Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
All Recalls
95,083 total recalls in our database
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
AGFA Healthcare
🏥 Medical Devices Class I - Dangerous
A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.
BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.
🏥 Medical Devices Class I - Dangerous
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Draegar Medical Systems
🏥 Medical Devices Class I - Dangerous
Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
🏥 Medical Devices Class I - Dangerous
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
🏥 Medical Devices Class I - Dangerous
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
🏥 Medical Devices Class I - Dangerous
Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
LED light bulbs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The LED light bulb's base can separate from the connector, posing an electrical shock hazard.
RZR 170 recreational off-highway vehicles (ROVs)
Aeon Motors Ltd., of Taiwan
🏠 Consumer Products Class I - Dangerous
The fuel tank neck can crack or the wiring harness can overheat or short circuit, posing fuel leak and fire hazards.
Quality Foam mattresses
Quality Foam, of Brooklyn, New York
🏠 Consumer Products Class I - Dangerous
The mattresses fail to meet the mandatory federal flammability standard for mattresses, posing a fire hazard.
Self-balancing scooters/hoverboards
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The lithium-ion battery packs in the self-balancing scooters/hoverboards can overheat, posing a risk of smoking, catching fire and/or exploding.
Women's scarves
Zhe Jiang Yin Suo Zhi Ran You Xian Gong Si, of China
🏠 Consumer Products Class II - Moderate
The women's scarves fail to meet the federal flammability standard for clothing textiles, posing a risk of burn injuries to consumers.
Winkel™ Colorburst activity toys
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The colored plastic tubes on the product can become brittle and break into small pieces, posing a choking hazard to infants.
Kite Hill Almond Yogurt, Peach, NET WT. 5.3 oz (150G) Case UPC: 8-56624-00415-9 Distributed by Lyrical Foods, Hayward, CA.
Lyrical Foods
🍎 Food Class I - Dangerous
Lyrical Foods is voluntarily recalling four flavors of Kite Hill Almond Yogurt with best by dates 07/03/17 and 07/04/17 as some of these packages have spoiled before the best by date.
LIL FISHERMAN PRE COOKED POLLOCK NUGGETS 1 OZ PUFI 1/10 LB
National Fish & Seafood
🍎 Food Class I - Dangerous
Product may contain undeclared milk.