45 results · 27ms · Sources: EU EUDAMED, US FDA

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Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·December 6, 2019

PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.

FDA Recall
Open, Classified ·LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente·Product code QBD·June 3, 2020

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

FDA Recall
Open, Classified ·Product code OGR·February 25, 2026

CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

FDA Recall
Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018

Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

FDA Recall
Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

FDA Recall
Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch

FDA Recall
Terminated ·Gambro Renal Products, Incorporated·Product code FLD·July 18, 2014

CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

FDA Recall
Open, Classified ·Custom Medical Specialties, Inc.·Product code FCH·September 20, 2016

Basic Biopsy Tray, Item Number NMBP44L

FDA Recall
Open, Classified ·American Contract Systems Inc.·Product code FCH·September 4, 2025

Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437

FDA Recall
Terminated ·Clark Research and Development Inc Number·Product code FLD·January 19, 2007

Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research and Development, Inc. Folsom, LA 70437

FDA Recall
Terminated ·Clark Research and Development Inc Number·Product code FLD·January 19, 2007

MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.

FDA Recall
Terminated ·Mesa Laboratories, Inc.·Product code FKH·May 12, 2017

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·May 18, 2023

Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·December 27, 2022

Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters

FDA Recall
Open, Classified ·NIPRO Technical Services, Inc.·Product code FKH·December 12, 2025

Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·April 8, 2024

Core Biopsy Tray Catalog Number: 8673R4

FDA Recall
Terminated ·Busse Hospital Disposables, Inc.·Product code FCH·February 22, 2022

Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·November 17, 2022

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·May 15, 2023

Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 175 mL, Clark Research and Development, Inc. Folsom, LA 70437

FDA Recall
Terminated ·Clark Research and Development Inc Number·Product code FLD·January 19, 2007