20 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
FDA Recall
Open, Classified
·Rebiscan, Inc.·Product code PMW·October 3, 2022
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·April 17, 2024
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·March 23, 2020
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
FDA Recall
Open, Classified
·PFM MEDICAL INC.·Product code DXE·April 21, 2026
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·April 11, 2025
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DXE·October 6, 2022
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
FDA Recall
Open, Classified
·T.G. Eakin Limited·Product code EXE·August 8, 2024
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DXE·September 7, 2023
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
FDA Recall
Open, Classified
·ConvaTec, Inc·Product code EXE·November 29, 2024
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code DXE·September 30, 2022
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
FDA Recall
Open, Classified
·Edwards Lifesciences, LLC·Product code DXE·October 6, 2022
VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
FDA Recall
Open, Classified
·Greiner Bio-One North America, Inc.·Product code JKA·May 14, 2024
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
FDA Recall
Open, Classified
·Greiner Bio-One North America, Inc.·Product code JKA·August 19, 2025
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
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
FDA Recall
Open, Classified
·Greiner Bio-One North America, Inc.·Product code JKA·December 12, 2023
VACUETTE SAFELINK, REF: 450210
FDA Recall
Open, Classified
·Greiner Bio-One GmbH Bad Haller Strase·Product code FMI·November 19, 2024
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
FDA Recall
Open, Classified
·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024
MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
FDA Recall
Open, Classified
·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: pressure ulcers leg ulcers cavity wounds lacerations post-operative surgical wounds
FDA Recall
Open, Classified
·Advanced Medical Solutions Ltd. Unit A 33 Road One Winsford United Kingdom·Product code NAC·October 1, 2024