Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 109 of 548
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and…
Olympus Corporation of the Americas
FDA Devices Moderate Aug 9, 2023
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulat…
Megadyne Medical Products, Inc.
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Mode…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Allura Xper FD10 and FD20. X-ray Imaging System.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model …
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYN…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model N…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Nu…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 9, 2023
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Johnson & Johnson Surgical Vision, Inc.
FDA Devices Moderate Aug 9, 2023
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical…
Olympus Corporation of the Americas
FDA Devices Moderate Aug 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model …
MEDLINE INDUSTRIES, LP - Northfield
CPSC Moderate Aug 3, 2023
Daikin Comfort Technologies Recalls Amana Packaged Terminal Air Conditioners and Heat Pumps Due to Burn and Fire Hazards (Recall Alert)
Daikin Comfort Technologies Manufacturing L.P. (DCT), of Houston, Texas
CPSC Moderate Aug 3, 2023
Philips Avent Digital Video Baby Monitors Recalled by Philips Personal Health Due to Burn Hazard
Philips Consumer Lifestyle B.V., of The Netherlands
FDA Devices Critical Aug 2, 2023
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants a…
Hamilton Medical, Inc.
FDA Devices Moderate Aug 2, 2023
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organi…
Qiagen GmbH
FDA Devices Critical Aug 2, 2023
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics…
Hamilton Medical, Inc.
FDA Devices Low Aug 2, 2023
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VIT…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Aug 2, 2023
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Datascope Corp.
FDA Devices Moderate Aug 2, 2023
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Datascope Corp.
FDA Devices Moderate Aug 2, 2023
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, design…
Davol, Inc.
FDA Devices Critical Aug 2, 2023
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Hamilton Medical, Inc.
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to …
Boston Scientific Corporation
FDA Devices Moderate Aug 2, 2023
vRad PACS with Mammography
Virtual Radiologic Corp.
FDA Devices Moderate Aug 2, 2023
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description …
Datascope Corp.
FDA Devices Moderate Aug 2, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of …
Qiagen GmbH
FDA Devices Moderate Aug 2, 2023
Ringed DxI Reaction Vessels (RVs)
Beckman Coulter, Inc.
FDA Devices Moderate Aug 2, 2023
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA,…
MICROVENTION INC.
FDA Devices Moderate Aug 2, 2023
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, design…
Davol, Inc.
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to…
Boston Scientific Corporation
FDA Devices Moderate Aug 2, 2023
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Aug 2, 2023
Trexo Device
Trexo Robotics Holdings Inc.
FDA Devices Moderate Aug 2, 2023
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngea…
Qiagen GmbH
FDA Devices Moderate Aug 2, 2023
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Amb…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN:…
Boston Scientific Corporation
FDA Devices Moderate Aug 2, 2023
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descriptio…
Datascope Corp.
FDA Devices Moderate Aug 2, 2023
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Datascope Corp.
FDA Devices Moderate Aug 2, 2023
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Medtronic Neuromodulation
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urologica…
Boston Scientific Corporation
FDA Devices Moderate Aug 2, 2023
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Argon Medical Devices, Inc
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UP…
Boston Scientific Corporation
FDA Devices Moderate Aug 2, 2023
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Datascope Corp.
FDA Drug Moderate Jul 26, 2023
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC:…
New England Life Care, Inc. dba Advanced Compounding Solutions
FDA Drug Moderate Jul 26, 2023
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801…
New England Life Care, Inc. dba Advanced Compounding Solutions
FDA Devices Moderate Jul 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Jul 26, 2023
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Olympus Corporation of the Americas
FDA Devices Moderate Jul 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR P…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Jul 26, 2023
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Olympus Corporation of the Americas
FDA Devices Moderate Jul 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b.…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jul 26, 2023
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Digisonics, Inc