13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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 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
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
RMU-2000 Automated Chest Compression Device
FDA Recall
Open, Classified
·Defibtech, LLC·Product code DRM·July 12, 2024
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
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
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
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
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Recall
Open, Classified
·DRE Medical Group Inc·Product code MNT·May 15, 2023