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Sources: EU EUDAMED, US FDA
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Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FRJ·January 20, 2016
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
HeartStart FR2+ Defibrillator
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·December 19, 2006
HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·January 15, 2020
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
FDA Recall
Open, Classified
·Philips North America LLC·Product code MKJ·February 9, 2021
Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5 Y-Adapter, SAP Finished Product Code 109838302.
FDA Recall
Terminated
·Avanos Medical, Inc.·Product code BSY·November 5, 2019
HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accordance with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC). The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC). The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 22, 2010
Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·February 28, 2007
HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·March 18, 2025
HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·May 28, 2010
MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.
FDA Recall
Open, Classified
·Product code OHR·May 4, 2026
Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·June 17, 2009