FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 43 of 520
Moderate Jan 22, 2025
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Intuitive Surgical, Inc.
Critical Jan 22, 2025
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 10508…
Mercury Enterprises, Inc. dba Mercury Medical
Moderate Jan 22, 2025
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS N…
Sklar Instruments
Moderate Jan 22, 2025
Change Healthcare Cardiology Hemodynamics software
A L I Technologies Ltd
Moderate Jan 22, 2025
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Moderate Jan 22, 2025
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Critical Jan 22, 2025
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Boston Scientific Corporation
Moderate Jan 22, 2025
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Intuitive Surgical, Inc.
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HO…
Sklar Instruments
Moderate Jan 22, 2025
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Sklar Instruments
Moderate Jan 15, 2025
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
GE Medical Systems, LLC
Moderate Jan 15, 2025
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
GE Medical Systems, LLC
Moderate Jan 15, 2025
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (para…
Beckman Coulter, Inc.
Moderate Jan 15, 2025
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
Moderate 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
Critical Jan 15, 2025
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA, LLC
Moderate Jan 15, 2025
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Aerin Medical, Inc.
Low Jan 15, 2025
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
Moderate Jan 15, 2025
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Spacelabs Healthcare, Inc.
Moderate Jan 15, 2025
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Descrip…
3B Medical, Inc.
Moderate Jan 15, 2025
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a compo…
Elucent Medical Inc
Moderate Jan 15, 2025
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Nipro Renal Soultions USA, Corporation
Moderate Jan 15, 2025
VACUETTE SAFELINK, REF: 450210
Greiner Bio-One GmbH
Moderate 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
Critical Jan 15, 2025
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
See DocMan
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 8, 2025
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Carwild Corporation
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Angiodynamics, Inc.
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Baxter Healthcare Corporation
Moderate Jan 8, 2025
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 8, 2025
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
Moderate Jan 8, 2025
Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 8, 2025
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Baxter Healthcare Corporation
Moderate Jan 1, 2025
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Abbott Vascular Inc
Moderate Jan 1, 2025
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
MEDLINE INDUSTRIES, LP - Northfield
Moderate Jan 1, 2025
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
Moderate Jan 1, 2025
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
MEDLINE INDUSTRIES, LP - Northfield