102 results
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12ms
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Sources: EU EUDAMED, US FDA
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
FDA Recall
Open, Classified
·Product code CAH·April 29, 2021
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
FDA Recall
Open, Classified
·Product code CAH·April 29, 2021
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
FDA Recall
Open, Classified
·Product code CAH·April 29, 2021
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
FDA Recall
Open, Classified
·Product code CAH·April 29, 2021
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 30, 2024
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 19, 2025
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
FDA Recall
Open, Classified
·Abbott Laboratories·Product code DDR·February 21, 2024
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CGR·August 4, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Recall
Open, Classified
·DRG International, Inc.·Product code CFP·October 7, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Recall
Open, Classified
·DRG International, Inc.·Product code JLX·September 13, 2024
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Recall
Open, Classified
·DRG International, Inc.·Product code KLI·October 18, 2021
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
FDA Recall
Open, Classified
·DRG International, Inc.·Product code CDZ·July 5, 2024
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Recall
Open, Classified
·DRG International, Inc.·Product code CDX·June 4, 2025
ORAcollect RNA: ORE-100
FDA Recall
Open, Classified
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code QJR·February 18, 2022
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
FDA Recall
Open, Classified
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code OYJ·February 18, 2022
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
FDA Recall
Open, Classified
·Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062·Product code HSB·December 21, 2023
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA Recall
Open, Classified
·Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062·Product code HSB·October 13, 2025
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
FDA Recall
Open, Classified
·Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062·Product code MBI·July 13, 2022
Phantom TTC Nail, 10.0 X 200mm, Right
FDA Recall
Open, Classified
·Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062·Product code HSB·December 21, 2023
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
FDA Recall
Open, Classified
·Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062·Product code HSB·December 21, 2023