16 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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HAWK Advanced Hypothermia Management Set, Item Number: 59-320
FDA Recall
Open, Classified
·Safeguard US Operating LLC·Product code IMD·August 27, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
FDA Recall
Open, Classified
·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).
FDA Recall
Open, Classified
·Safeguard US Operating LLC·Product code IMD·August 27, 2024
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
FDA Recall
Open, Classified
·Zyno Medical LLC·Product code FRN·December 20, 2023
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
FDA Recall
Open, Classified
·Zyno Medical LLC·Product code FRN·September 13, 2024
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
FDA Recall
Open, Classified
·Jiangsu Well Biotech Co., Ltd. No·Product code QKP·August 9, 2022
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.
FDA Recall
Open, Classified
·Microtek Medical, Inc.·Product code PUI·April 13, 2025
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
FDA Recall
Open, Classified
·InfuTronix LLC·Product code FRN·October 19, 2021
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
FDA Recall
Open, Classified
·Zyno Medical LLC·Product code FRN·June 4, 2024