69 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Bodor P and C series laser cutting machines
FDA Recall
Open, Classified
·Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China·Product code RFE·December 19, 2024
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
FDA Recall
Open, Classified
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·May 14, 2021
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OKG·April 8, 2024
BostonSight SCLERAL Lens
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
BostonSight PROSE Lens.
FDA Recall
Open, Classified
·Boston Foundation For Sight·Product code HQD·June 10, 2025
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Recall
Open, Classified
·Philips Healthcare·Product code OWB·September 24, 2021
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
FDA Recall
Open, Classified
·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·December 10, 2020
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
FDA Recall
Open, Classified
·Abbott Medical·Product code PNJ·May 12, 2026
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
FDA Recall
Open, Classified
·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code KRI·June 27, 2025
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code ERA·May 9, 2025
Permobil TiLite, Models: Aero Z, and ZRA
FDA Recall
Open, Classified
·TiSport, Llc·Product code IOR·September 24, 2021
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
FDA Recall
Open, Classified
·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
FDA Recall
Open, Classified
·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
FDA Recall
Open, Classified
·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
FDA Recall
Open, Classified
·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A
FDA Recall
Open, Classified
·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025
Merlin PCS 3650 programmer Model 3330 software
FDA Recall
Open, Classified
·St. Jude Medical, Cardiac Rhythm Management Division·Product code OSR·March 10, 2022
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
FDA Recall
Open, Classified
·Bebig Isotopentechnik Gmbh Robert-Rossle-Str. 10 Berlin Germany·Product code MUJ·October 17, 2023
Merlin 2 PCS MER3700 programmer Model MER3400 software
FDA Recall
Open, Classified
·St. Jude Medical, Cardiac Rhythm Management Division·Product code NIK·March 10, 2022
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
FDA Recall
Open, Classified
·Accriva Diagnostics, Inc.·Product code JBP·November 5, 2025