66 results · 15ms · Sources: EU EUDAMED, US FDA

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Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

FDA Recall
Terminated ·JAS Diagnostics Inc.·Product code CFR·October 23, 2014

Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

FDA Recall
Terminated ·JAS Diagnostics Inc.·Product code CGA·April 7, 2014

Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.

FDA Recall
Terminated ·Cook OB/Gyn, Inc.·Product code HFE·April 2, 2009

Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

FDA Recall
Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

FDA Recall
Terminated ·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016

Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

FDA Recall
Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

FDA Recall
Open, Classified ·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025

12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·May 8, 2009

Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

FDA Recall
Terminated ·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013

Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FDE·September 4, 2024

Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

FDA Recall
Terminated ·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

X-ray, Computed Tomography, Model TSX101A

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAK·January 14, 2003

Digital Radiography System Model DFP-8000D/FPD,

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005

Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code LNH·January 27, 2004

Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYN·October 2, 2007

NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYO·August 29, 2007

Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code JAK·October 1, 2007

Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code LNH·August 24, 2004

Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code IYN·February 2, 2007