Medical Devices Recalls

GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5…

GE Medical Systems, LLC

FDA Devices Critical Jan 15, 2025

GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB

GE Medical Systems, LLC

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi USA, LLC

FDA Devices Low Jan 15, 2025

Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

Aerin Medical, Inc.

The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For …

Qualigen Inc

Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

Spacelabs Healthcare, Inc.

Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Descrip…

3B Medical, Inc.

EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a compo…

Elucent Medical Inc

Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

Nipro Renal Soultions USA, Corporation

VACUETTE SAFELINK, REF: 450210

Greiner Bio-One GmbH

FDA Devices Critical Jan 15, 2025

GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-4…

GE Medical Systems, LLC

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD

FDA Drug Moderate Jan 8, 2025

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 630…

Hikma Injectables USA Inc

Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ…

MEDLINE INDUSTRIES, LP - Northfield

Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, …

MEDLINE INDUSTRIES, LP - Northfield

Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANT…

MEDLINE INDUSTRIES, LP - Northfield

See DocMan

MEDLINE INDUSTRIES, LP - Northfield

Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF

MEDLINE INDUSTRIES, LP - Northfield

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2…

Medtronic Neuromodulation

Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR H…

MEDLINE INDUSTRIES, LP - Northfield

Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237

Carwild Corporation

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, …

Medtronic Neuromodulation

SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid fro…

Med Michigan Holding Llc

AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

Angiodynamics, Inc.

Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY…

MEDLINE INDUSTRIES, LP - Northfield

Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE …

MEDLINE INDUSTRIES, LP - Northfield

Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.

MEDLINE INDUSTRIES, LP - Northfield

Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206

Carwild Corporation

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

Baxter Healthcare Corporation

Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.

MEDLINE INDUSTRIES, LP - Northfield

Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fl…

Carwild Corporation

Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.

MEDLINE INDUSTRIES, LP - Northfield

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

Baxter Healthcare Corporation

20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

Abbott Vascular Inc

ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A …

SEASPINE ORTHOPEDICS CORPORATION

KIT,SPINE LH Convenience kit, SKU DYNJ906448A.

MEDLINE INDUSTRIES, LP - Northfield

Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

Siemens Healthcare Diagnostics, Inc.

SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.

MEDLINE INDUSTRIES, LP - Northfield

Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in hu…

Beckman Coulter, Inc.

20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic de…

Abbott Vascular Inc

FDA Devices Critical Jan 1, 2025

ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870

MEDLINE INDUSTRIES, LP - Northfield

StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

Nova Biomedical Corporation

epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…

Siemens Healthcare Diagnostics, Inc.

STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790

MEDLINE INDUSTRIES, LP - Northfield

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

Encore Medical, LP

FDA Devices Critical Jan 1, 2025

epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…

Siemens Healthcare Diagnostics, Inc.

StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient te…

Nova Biomedical Corporation

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

Hologic, Inc.