Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO ST...
Medical Devices·7,730 affected·Dec 3, 2024
High RiskFDA
A L I Technologies Ltd
Change Healthcare Cardiology Hemo software
Medical Devices·204 affected·Dec 2, 2024
High RiskFDA
Accriva Diagnostics, Inc.
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Medical Devices·25 affected·Dec 2, 2024
High RiskFDA
A L I Technologies Ltd
McKesson Cardiology Hemo software
Medical Devices·1 affected·Dec 2, 2024
CriticalFDA
Trokamed Gmbh
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Medical Devices·53 affected·Nov 27, 2024
CriticalFDA
Trokamed Gmbh
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
Medical Devices·42 affected·Nov 27, 2024
High RiskFDA
Isotis Orthobiologics, Inc.
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Medical Devices·22 affected·Nov 27, 2024
High RiskFDA
Isotis Orthobiologics, Inc.
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Medical Devices·145 affected·Nov 27, 2024
CriticalFDA
Trokamed Gmbh
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Medical Devices·34 affected·Nov 27, 2024
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
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
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
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
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
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
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
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
Cook Biotech, Inc.
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Medical Devices·10 affected·Nov 22, 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
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
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
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
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIR...
Medical Devices·1,236 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833...
Medical Devices·3,903 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
Medical Devices·1,494 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
Medical Devices·80 affected·Nov 21, 2024
High RiskFDA
Philips North America Llc
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Medical Devices·4,811 affected·Nov 20, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Medical Devices·1 affected·Nov 19, 2024
High RiskFDA
Greiner Bio-one Gmbh
VACUETTE SAFELINK, REF: 450210
Medical Devices·188,800 affected·Nov 19, 2024
High RiskFDA
Ge Medical Systems, Llc
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Medical Devices·644 affected·Nov 18, 2024
High RiskFDA
Ge Medical Systems, Llc
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Medical Devices·8,319 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Medical Devices·1,464 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Medical Devices·250 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Medical Devices·768 affected·Nov 18, 2024
High RiskFDA
Elucent Medical Inc
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushio...
Medical Devices·283 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Medical Devices·360 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Medical Devices·1,332 affected·Nov 18, 2024
High RiskFDA
Philips North America Llc
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Medical Devices·301 affected·Nov 16, 2024
High RiskFDA
Mint Medical Gmbh
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Medical Devices·65 affected·Nov 15, 2024
High RiskFDA
Mint Medical Gmbh
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Medical Devices·18 affected·Nov 15, 2024
High RiskFDA
Carefusion 303, Inc.
BD Pyxis CII Safe ES, REF: 1116-00
Medical Devices·218 affected·Nov 14, 2024
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
Medical Devices·40,763 affected·Nov 14, 2024
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES, REF: 323
Medical Devices·98,526 affected·Nov 14, 2024