Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 177 of 548
FDA Devices Moderate Jun 23, 2021
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
FDA Devices Moderate Jun 23, 2021
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who…
Covidien, LP
FDA Devices Moderate Jun 23, 2021
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
FDA Devices Moderate Jun 23, 2021
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based el…
Abbott Laboratories Inc. (St Jude Medical)
FDA Devices Moderate Jun 23, 2021
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
FDA Devices Moderate Jun 23, 2021
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
FDA Devices Moderate Jun 23, 2021
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Medtronic Perfusion Systems
FDA Devices Moderate Jun 23, 2021
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
FDA Devices Moderate Jun 23, 2021
VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS…
Bard Peripheral Vascular Inc
FDA Devices Moderate Jun 23, 2021
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Abbott Laboratories Inc. (St Jude Medical)
FDA Devices Moderate Jun 23, 2021
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor…
Skytron, Div. The KMW Group, Inc
FDA Devices Moderate Jun 23, 2021
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
FDA Devices Moderate Jun 23, 2021
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Sur…
Windstone Medical Packaging, Inc.
FDA Devices Moderate Jun 23, 2021
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Radiometer Medical ApS
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Alphatec Spine, Inc.
FDA Devices Critical Jun 16, 2021
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Avid Medical, Inc.
FDA Devices Moderate Jun 16, 2021
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The My…
Nico Corp.
FDA Devices Moderate Jun 16, 2021
Quanta System Sterile Optical Laser Fiber, reusable
Quanta System, S.p.A.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
Alphatec Spine, Inc.
FDA Devices Critical Jun 16, 2021
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Avid Medical, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Hardy Diagnostics
FDA Devices Critical Jun 16, 2021
COVID-19 Self-Test Kit *** INNOVA *** 3T
INNOVA MEDICAL GROUP, INC.
FDA Devices Moderate Jun 16, 2021
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with …
Viewray, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be u…
Medline Industries Inc
FDA Devices Moderate Jun 16, 2021
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Normand-Info S.A.S.U.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional…
CooperSurgical, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
Alphatec Spine, Inc.
FDA Devices Low Jun 16, 2021
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the …
MICROVENTION INC.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
Alphatec Spine, Inc.
FDA Devices Low Jun 16, 2021
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the …
MICROVENTION INC.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
Alphatec Spine, Inc.
FDA Devices Critical Jun 16, 2021
DeRoyal Angio Cath Removal Tray, REF 89-9936.02
DeRoyal Industries Inc
FDA Devices Critical Jun 16, 2021
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
INNOVA MEDICAL GROUP, INC.
FDA Devices Moderate Jun 16, 2021
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque buil…
Sunstar Americas, Inc.
FDA Devices Critical Jun 16, 2021
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
Avid Medical, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
Alphatec Spine, Inc.
FDA Devices Moderate Jun 16, 2021
Olympus Sterile Optical Laser Fiber, single use and reusable
Quanta System, S.p.A.
FDA Devices Moderate Jun 16, 2021
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide corre…
Medtronic Sofamor Danek USA, Inc
FDA Devices Moderate Jun 16, 2021
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Philips North America Llc