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U.S. Department of Health and Human Services

Medical Device Recalls
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iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in... 3 11/01/2024 Iotamotion Inc
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that include... 3 10/30/2024 Trackx Technology Inc
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic... 3 10/29/2024 DRG International, Inc.
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702,... 3 10/16/2024 Beckman Coulter, Inc.
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to ... 3 09/30/2024 Maquet Medical Systems USA
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal 3 09/25/2024 T.G. Eakin Limited
BiomarC EX Fiducial Marker System, Catalog Number 040165 3 09/17/2024 Carbon Medical Technologies, Inc.
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An e... 3 08/15/2024 DRG International, Inc.
NavaClick Syringe and Needle, Model Number LIN02 3 08/08/2024 LINEAGE BIOMEDICAL, INC
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemi... 3 07/01/2024 Ortho-Clinical Diagnostics, Inc.

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