92 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·November 15, 2023
Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number DYNDC3274; 6) MYELOGRAM TRAY, Pack Number DYNDH1531; 7) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 8) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 9) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 10) LUMBAR PUNCTURE TRAY, Pack Number PT215; 11) FINE LACERATION KIT, Pack Number SUT19360
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·April 8, 2024
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·May 15, 2023
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·November 15, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FKG·May 18, 2023
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
FDA Recall
Open, Classified
·Product code FKG·January 8, 2026
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
FDA Recall
Open, Classified
·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code KRI·June 27, 2025
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
FDA Recall
Open, Classified
·Straumann USA LLC·Product code MQC·June 25, 2021
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
FDA Recall
Open, Classified
·Keystone Industries·Product code MQC·November 20, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438·Product code FCG·August 2, 2024
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FCG·May 25, 2022
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCG·April 8, 2024
EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
FDA Recall
Open, Classified
·Cook Medical Incorporated·Product code FCG·April 1, 2024
Neurotransmitters XL
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CKG·November 3, 2025
Neurotransmitters Plus
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CKG·November 3, 2025
EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
FDA Recall
Open, Classified
·Cook Medical Incorporated·Product code FCG·April 1, 2024