85 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
FDA Recall
Open, Classified
·Telcare, LLC·Product code NBW·January 30, 2025
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FRO·May 25, 2022
Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code HGM·October 24, 2025
Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
FDA Recall
Open, Classified
·Philips North America Llc·Product code HGM·May 26, 2026
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
FDA Recall
Open, Classified
·Philips North America Llc·Product code HGM·May 26, 2026
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code HGM·October 24, 2025
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
FDA Recall
Open, Classified
·Philips North America Llc·Product code HGM·May 22, 2024
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code HGM·October 24, 2025
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pediatric care bed; Product Designation: KayserBett IDA;
FDA Recall
Open, Classified
·KAYSERBETTEN GMBH & CO. KG Rieper Str. 12 Bad Fallingbostel Germany·Product code FNL·May 4, 2026
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
FDA Recall
Open, Classified
·Macherey Nagel Gmbh & Co. Kg Valencienner Str. 11 Duren Germany·Product code JIL·April 4, 2024
Alinity ci Level Sensor, Bulk Solution
FDA Recall
Open, Classified
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019
Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
FDA Recall
Open, Classified
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany·Product code LXH·September 11, 2024
Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
FDA Recall
Open, Classified
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·September 16, 2019
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
FDA Recall
Open, Classified
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code LCD·April 24, 2020