21 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.
FDA Recall
Open, Classified
·WASATCH PHOTONICS·Product code REM·August 4, 2025
Alcohol (ALC) Test Saliva
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DIC·November 3, 2025
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTD·June 4, 2024
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KQM·June 4, 2024
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTD·June 4, 2024
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
FDA Recall
Open, Classified
·Dutch Ophthalmic USA, Inc.·Product code HQF·April 14, 2021
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
FDA Recall
Open, Classified
·Brasseler USA I Lp·Product code EJL·January 11, 2024
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
FDA Recall
Open, Classified
·Young Dental Manufacturing I, LLC·Product code FLG·August 23, 2024
BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
FDA Recall
Open, Classified
·Young Dental Manufacturing I, LLC·Product code LBH·May 23, 2023
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
FDA Recall
Open, Classified
·Young Dental Manufacturing I, LLC·Product code EJR·May 13, 2024
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
FDA Recall
Open, Classified
·Young Dental Manufacturing I, LLC·Product code EGS·October 6, 2023
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
FDA Recall
Open, Classified
·Young Dental Manufacturing I, LLC·Product code JET·December 5, 2022
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.
FDA Recall
Open, Classified
·Young Dental Mfg Co I LLC·Product code JOJ·December 29, 2021
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
FDA Recall
Open, Classified
·North Coast Medical Inc·Product code ILH·August 18, 2023
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Recall
Open, Classified
·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
FDA Recall
Open, Classified
·Dental EZ Group Star Dental Division·Product code ELC·May 30, 2024
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Recall
Open, Classified
·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
FDA Recall
Open, Classified
·Sonendo Inc·Product code ELC·October 14, 2022
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Recall
Open, Classified
·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
FDA Recall
Open, Classified
·Sonendo Inc·Product code ELC·October 14, 2022