103 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code OMN·October 7, 2025
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Recall
Open, Classified
·Meridian Bioscience Inc·Product code NJR·October 7, 2025
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
FDA Recall
Open, Classified
·Oakworks Inc·Product code LGX·December 5, 2023
24K Premium Lense, Distributed by Updream Inc.
FDA Recall
Open, Classified
·Ontact Inc 10944 Playa Del Sol·Product code MVN·March 20, 2024
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
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code HXK·May 18, 2023
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
FDA Recall
Open, Classified
·Lacrimedics Inc·Product code LZU·January 17, 2022
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
FDA Recall
Open, Classified
·Lacrimedics Inc·Product code LZU·January 17, 2022
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FMF·August 7, 2023
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FMF·August 7, 2023
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Recall
Open, Classified
·New Standard Device Inc·Product code KTT·July 23, 2019
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
FDA Recall
Open, Classified
·Immuno-Mycologics, Inc·Product code PPM·March 26, 2026
Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code KYB·November 13, 2024
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
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
FDA Recall
Open, Classified
·PREMIA SPINE LTD Giborey Israel 7 Ramat Poleg Netanya Israel·Product code QWK·July 16, 2025
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
FDA Recall
Open, Classified
·Aesculap Implant Systems LLC·Product code GWG·July 20, 2023