104 results · 19ms · Sources: EU EUDAMED, US FDA

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Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·February 21, 2025

AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

FDA Recall
Terminated ·Zoll Circulation, Inc.·Product code DRM·August 8, 2012

AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

FDA Recall
Open, Classified ·ZOLL Circulation, Inc.·Product code DRM·September 22, 2022

Michigan Instruments Thumper Mechanical CPR Device; Model 1007.

FDA Recall
Terminated ·Michigan Instruments, Inc.·Product code DRM·August 4, 2006

Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

FDA Recall
Terminated ·Zoll Circulation, Inc.·Product code DRM·July 16, 2013

LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

FDA Recall
Open, Classified ·Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden·Product code DRM·May 21, 2025

LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevagen 17 SE-223 70 LUND Sweden***www.jolife.com***". Designed to uninterrupted chest compressions at a consistent rate and depth.

FDA Recall
Terminated ·Jolife AB Ideon, Scheelev·Product code DRM·February 8, 2011

Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

FDA Recall
Terminated ·Michigan Instruments, Inc.·Product code DRM·February 13, 2018

RMU-2000 Automated Chest Compression Device

FDA Recall
Open, Classified ·Defibtech, LLC·Product code DRM·July 12, 2024

Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

FDA Recall
Terminated ·Zoll Circulation, Inc.·Product code DRM·January 28, 2008

Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

FDA Recall
Open, Classified ·ZOLL Circulation, Inc.·Product code DRM·March 4, 2025

Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.

FDA Recall
Terminated ·Michigan Instruments, Inc.·Product code DRM·September 14, 2006

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

FDA Recall
Open, Classified ·Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden·Product code DRM·April 13, 2026

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

FDA Recall
Terminated ·Mako Surgical Corporation·Product code OLO·December 1, 2017

Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Stryker Orthopaedics; Howmedica Osteonics Copr. 325 Corporate Drive Mahwah, NJ 07430

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code HRY·November 25, 2008

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023

CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

FDA Recall
Terminated ·DRG International Inc·Product code JSO·November 9, 2009

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CFP·October 7, 2024

CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

FDA Recall
Terminated ·DRG International Inc·Product code JSO·November 9, 2009

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