52 results
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24ms
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Sources: EU EUDAMED, US FDA
Trumpet, Needle Guide, Cat# TMS-200
FDA Recall
Open, Classified
·Technicality Inc.·Product code MDM·January 31, 2024
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
FDA Recall
Open, Classified
·NIPRO Technical Services, Inc.·Product code FKH·December 12, 2025
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
FDA Recall
Open, Classified
·W & H DENTALWERK BUERMOOS GMBH Ignaz Glaser Strase 53 53 IGNAZ-GLASER-STRASSE BUERMOOS Austria·Product code KMW·January 16, 2024
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code OZN·December 5, 2025
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJX·May 18, 2023
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code QJR·December 15, 2022
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
FDA Recall
Open, Classified
·Accriva Diagnostics, Inc.·Product code GGN·April 30, 2026
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
FDA Recall
Open, Classified
·Zoe Medical Incorporated·Product code DQA·August 13, 2024
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
FDA Recall
Open, Classified
·Zoe Medical Incorporated·Product code DQA·August 13, 2024
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
FDA Recall
Open, Classified
·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·March 26, 2024
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code HKO·February 18, 2026
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
FDA Recall
Open, Classified
·C.A. Greiner & Sohne Gesellschaftmbh Greiner St. # 70 Kremsmunster Austria·Product code FMI·July 27, 2020
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code PDJ·February 9, 2022
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code NDW·February 9, 2022
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CJY·February 9, 2022
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code LCP·February 9, 2022
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