10,000 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYRINGE 1ML S/T W/NDL 26X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 17, 2019
SYRINGE 1ML S/T W/NDL 26X5/8 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2019
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
FDA Enforcement
Class II
·Ongoing·Edge Biologicals Inc·April 30, 2025
CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·December 18, 2002
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
FDA Enforcement
Class II
·Ongoing·Copan Italia·December 24, 2025
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 7, 2018
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
FDA Recall
Open, Classified
·Greiner Bio-One North America, Inc.·Product code GIM·August 8, 2025
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 31, 2019
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·July 31, 2019
Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMI·June 29, 2004
LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
FDA Recall
Open, Classified
·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
FDA Recall
Open, Classified
·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 22, 2023
Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Class II
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
FDA Enforcement
Class II
·Ongoing·Immuno-Mycologics, Inc·March 26, 2025
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code MEG·October 25, 2005
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FMF·December 28, 2023
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code FMF·December 28, 2023
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023