PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 39 of 548

FDA Devices Critical Mar 12, 2025

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

Baxter Healthcare Corporation

FDA Devices Moderate Mar 12, 2025

Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;

Telcare, LLC

CPSC Moderate Mar 6, 2025

Black Diamond Equipment Recalls BD Recon LT Avalanche Transceivers Due to Risk of Loss of Emergency Communications; Risk of Serious Injury or Death

CPSC Moderate Mar 6, 2025

Taylor Water Technologies Recalls Phosphate Reagent Bottles Sold with Test Kits Due to Risk of Severe Chemical Burns; Violation of Federal Regulation…

Taylor Water Technologies LLC, of Sparks, Maryland

FDA Devices 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

FDA Devices 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

FDA Devices Moderate Mar 5, 2025

ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.

TERRAGENE S.A.

FDA Devices Moderate Mar 5, 2025

Brivo MR355, NMRI system

GE Healthcare (China) Co., Ltd.

FDA Devices 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

FDA Devices 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.

FDA Devices 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

FDA Devices 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

FDA Devices 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

FDA Devices 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

FDA Devices 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

FDA Devices 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

FDA Devices Moderate Mar 5, 2025

SIGNA Creator, SIGNA Explorer, NMRI systems

GE Healthcare (China) Co., Ltd.

FDA Devices 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

FDA Devices 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

FDA Devices Moderate Mar 5, 2025

SIGNA MR355, SIGNA MR360, NMRI system

GE Healthcare (China) Co., Ltd.

FDA Devices 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

FDA Devices 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.

FDA Devices 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

FDA Devices 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

FDA Devices 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

FDA Devices 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

FDA Devices 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.

FDA Devices Moderate Mar 5, 2025

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

FDA Devices 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

CPSC Moderate Feb 27, 2025

ARVA Recalls NEO BT PRO Avalanche Transceivers Due to Risk of Loss of Emergency Transmission; Risk of Serious Injury or Death

CPSC Moderate Feb 27, 2025

Head Rush Technologies Recalls TRUBLUE iQ and TRUBLUE iQ+ Auto Belays Due to Fall Hazard

Head Rush Technologies, of Louisville, Colorado

FDA Devices 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

FDA Devices Moderate Feb 26, 2025

3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack …

KCI USA, INC.

FDA Devices Moderate Feb 26, 2025

remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

Remel, Inc

FDA Devices Moderate Feb 26, 2025

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.1…

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Feb 26, 2025

Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.…

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Feb 26, 2025

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001

Dexcom, Inc.

FDA Devices Critical Feb 26, 2025

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Feb 26, 2025

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 26, 2025

3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel an…

KCI USA, INC.

FDA Devices Moderate Feb 26, 2025

DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement

DeRoyal Industries Inc

FDA Devices Moderate Feb 26, 2025

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

Dexcom, Inc.

FDA Devices Critical Feb 26, 2025

Allura CV20; Catalog numbers: 722031

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Feb 26, 2025

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: …

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Feb 26, 2025

AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

Hollister Incorporated

FDA Devices Moderate Feb 26, 2025

AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

Hollister Incorporated

FDA Devices Moderate Feb 26, 2025

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia

Augustine Temperature Management, LLC

FDA Devices Critical Feb 26, 2025

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Feb 26, 2025

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 15415…

Spectranetics Corporation

FDA Devices Moderate Feb 26, 2025

Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number …

MEDLINE INDUSTRIES, LP - Northfield