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High RiskFDA
O&m Halyard, Inc.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy P...
Medical Devices·1,440 affected·Nov 26, 2024
High RiskFDA
Macleods Pharmaceuticals Ltd
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured f...
Oral Drugs·15,744 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Typ...
Surgical Devices·128,608 affected·Nov 25, 2024
High RiskFDA
Spacelabs Healthcare, Ltd.
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory...
Medical Devices·13,202 affected·Nov 25, 2024
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) ...
Medical Devices·281 affected·Nov 25, 2024
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Medical Devices·53 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·112 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Ty...
Surgical Devices·495,865 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·4,055 affected·Nov 25, 2024
High RiskFDA
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Medical Devices·2,265 affected·Nov 25, 2024
High RiskFDA
Angiodynamics, Inc.
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Medical Devices·138 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·84,570 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Typ...
Surgical Devices·36,712 affected·Nov 25, 2024
High RiskFDA
Spacelabs Healthcare, Ltd.
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to re...
Medical Devices·1,779 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type...
Surgical Devices·9,200 affected·Nov 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model N...
Surgical Devices·34,325 affected·Nov 25, 2024
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; ...
Medical Devices·120 affected·Nov 25, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Respiratory Devices·6,280 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Respiratory Devices·2,010 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Respiratory Devices·2,440 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Respiratory Devices·2,610 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Respiratory Devices·5,120 affected·Nov 24, 2024
High RiskFDA
Provepharm Inc.
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springho...
Injectable Drugs·2,160 affected·Nov 22, 2024
High RiskFDA
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured ...
Injectable Drugs·5,209 affected·Nov 22, 2024
High RiskFDA
Generitech Corporation
10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Profession...
Drugs·77 affected·Nov 22, 2024
High RiskFDA
Apothecus Pharmaceutical Corp.
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmac...
Topical Drugs·33,659 affected·Nov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Medical Devices·6 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices·670 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices·276 affected·Nov 22, 2024
High RiskFDA
3m Company - Health Care Business
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-83...
Medical Devices·171 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical pr...
Diagnostic Devices·2,240 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical profes...
Diagnostic Devices·6,738 affected·Nov 22, 2024
High RiskFDA
Nipro Renal Soultions Usa, Corporation
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Medical Devices·2,810 affected·Nov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Medical Devices·49 affected·Nov 22, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical prof...
Diagnostic Devices·320 affected·Nov 22, 2024
High RiskFDA
Cook Biotech, Inc.
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Medical Devices·10 affected·Nov 22, 2024
High RiskFDA
Sugar Foods Llc
Fresh Gourmet TORTILLA STRIPS SANTA FE SYTLE NET WT 3.5 OZ (99g) UPC 7 87359 17504 6 DISTRIBUTED BY: FRESH GOURMET CO. WESTLAKE VILLAGE, ...
Food·5,000 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA P...
Cardiac Devices·2,344 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KI...
Medical Devices·2,664 affected·Nov 21, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assi...
Surgical Devices·84 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ3518...
Medical Devices·182 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
See DocMan
Medical Devices·205,360 affected·Nov 21, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and...
Surgical Devices·100 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Medical Devices·128 affected·Nov 21, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP a...
Medical Implants·566 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177;...
Medical Devices·1,402 affected·Nov 21, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app v...
Medical Implants·59 affected·Nov 21, 2024
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide...
Cardiac Devices·78 affected·Nov 21, 2024