FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 37 of 520
Moderate Mar 12, 2025
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crown…
Hiossen Inc.
Moderate Mar 12, 2025
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prost…
Hiossen Inc.
Critical Mar 12, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-…
Micro Therapeutics, Inc.
Moderate Mar 12, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
Becton Dickinson & Co.
Moderate Mar 12, 2025
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Kung Shin Plastics Co. Ltd.
Moderate Mar 12, 2025
Vios Monitoring System Bedside Monitor Model BSM2050
Murata Vios, Inc.
Moderate Mar 12, 2025
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.…
Medimaps Group
Moderate Mar 12, 2025
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regu…
Beckman Coulter, Inc.
Moderate Mar 12, 2025
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Medtronic MiniMed, Inc.
Critical Mar 12, 2025
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 8…
Bard Peripheral Vascular Inc
Moderate Mar 12, 2025
MIM software; System, Image Processing, Radiological
MIM Software Inc
Moderate Mar 12, 2025
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6…
Kung Shin Plastics Co. Ltd.
Moderate Mar 12, 2025
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Medtronic MiniMed, Inc.
Moderate Mar 12, 2025
Paradigm REF: MMT-712 and MMT-715
Medtronic MiniMed, Inc.
Moderate Mar 12, 2025
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crown…
Hiossen Inc.
Critical Mar 12, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-…
Micro Therapeutics, Inc.
Moderate Mar 12, 2025
MiniMed insulin pump, REF: 620G (MMT-1750)
Medtronic MiniMed, Inc.
Moderate Mar 12, 2025
Paradigm insulin pump, REF: MMT-754
Medtronic MiniMed, Inc.
Moderate Mar 12, 2025
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Medtronic MiniMed, Inc.
Moderate Mar 12, 2025
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crown…
Hiossen Inc.
Moderate Mar 12, 2025
ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns…
Hiossen Inc.
Moderate Mar 12, 2025
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Medtronic MiniMed, Inc.
Critical Mar 12, 2025
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
Baxter Healthcare Corporation
Moderate Mar 12, 2025
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Telcare, LLC
Moderate Mar 5, 2025
A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number…
Tyber Medical
Moderate Mar 5, 2025
A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number:…
Tyber Medical
Moderate Mar 5, 2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
TERRAGENE S.A.
Moderate Mar 5, 2025
Brivo MR355, NMRI system
GE Healthcare (China) Co., Ltd.
Moderate Mar 5, 2025
A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Num…
Tyber Medical
Moderate Mar 5, 2025
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous o…
CareFusion 303, Inc.
Moderate Mar 5, 2025
A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number:…
Tyber Medical
Moderate Mar 5, 2025
A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal…
Tyber Medical
Moderate Mar 5, 2025
A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number…
Tyber Medical
Moderate Mar 5, 2025
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
Tyber Medical
Moderate Mar 5, 2025
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to …
Tyber Medical
Moderate Mar 5, 2025
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Mo…
Tyber Medical
Moderate Mar 5, 2025
SIGNA Creator, SIGNA Explorer, NMRI systems
GE Healthcare (China) Co., Ltd.
Moderate Mar 5, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, t…
Pentax of America Inc
Moderate Mar 5, 2025
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia …
Tyber Medical
Moderate Mar 5, 2025
SIGNA MR355, SIGNA MR360, NMRI system
GE Healthcare (China) Co., Ltd.
Moderate Mar 5, 2025
A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number…
Tyber Medical
Moderate Mar 5, 2025
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MED…
CareFusion 303, Inc.
Moderate Mar 5, 2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastroint…
Pentax of America Inc
Moderate Mar 5, 2025
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
LEICA BIOSYSTEMS NUSSLOCH GMBH
Moderate Mar 5, 2025
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
Tyber Medical
Moderate Mar 5, 2025
A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the …
Tyber Medical
Moderate Mar 5, 2025
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS…
CareFusion 303, Inc.
Moderate Mar 5, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Moderate Mar 5, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointe…
Pentax of America Inc
Moderate Feb 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.…
RAYSEARCH LABORATORIES AB