190 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Recall
Terminated
·Product code FPA·November 7, 2014
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
FDA Recall
Open, Classified
·Abbott Medical·Product code PNJ·May 12, 2026
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
FDA Recall
Open, Classified
·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code DPZ·May 19, 2023
Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD, Inc., St. Paul, MN 55112 USA; RX ONLY.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FRN·January 19, 2007
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Recall
Open, Classified
·Abbott Medical·Product code PNJ·November 21, 2024
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
FDA Recall
Open, Classified
·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code DPZ·May 19, 2023
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO
FDA Recall
Open, Classified
·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Recall
Completed
·Greiner Bio-One North America, Inc.·Product code JKA·March 31, 2023
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·December 9, 2021
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
FDA Recall
Terminated
·Abbott·Product code NIK·February 28, 2020
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
FDA Recall
Terminated
·St Jude Medical Inc.·Product code NIK·August 28, 2017
VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
FDA Recall
Terminated
·Cellestis Inc·Product code NCD·September 27, 2012
Merlin PCS 3650 programmer Model 3330 software
FDA Recall
Open, Classified
·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022
Merlin PCS 3650 programmer Model 3330 software
FDA Recall
Open, Classified
·St. Jude Medical, Cardiac Rhythm Management Division·Product code OSR·March 10, 2022
St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
FDA Recall
Terminated
·St Jude Medical CRMD·Product code KRG·October 6, 2006
Merlin 2 PCS MER37000 programmer Model MER3400 software
FDA Recall
Open, Classified
·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
FDA Recall
Terminated
·St Jude Medical Inc.·Product code OSR·April 16, 2018
Merlin 2 PCS MER3700 programmer Model MER3400 software
FDA Recall
Open, Classified
·St. Jude Medical, Cardiac Rhythm Management Division·Product code NIK·March 10, 2022
Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
FDA Recall
Terminated
·St Jude Medical Inc.·Product code MXC·April 16, 2018
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
FDA Recall
Terminated
·Cook Inc.·Product code PYC·April 9, 2019