Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Securitas Healthcare Llc
Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Medical Devices·1,235 affected·Sep 25, 2023
High RiskFDA
Townsend Design
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Medical Devices·334 affected·Sep 23, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Medical Devices·3,136 affected·Sep 22, 2023
CriticalFDA
B. Braun Medical, Inc.
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
Medical Devices·9,771 affected·Sep 21, 2023
High RiskFDA
Roi Cps Llc
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Medical Devices·134 affected·Sep 21, 2023
CriticalFDA
B. Braun Medical, Inc.
8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
Medical Devices·884 affected·Sep 21, 2023
High RiskFDA
Acclarent, Inc.
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Medical Devices·141 affected·Sep 21, 2023
CriticalFDA
Cardinal Health 200, Llc
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Medical Devices·3,113,846 affected·Sep 20, 2023
CriticalFDA
Cardinal Health 200, Llc
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Medical Devices·4,913,520 affected·Sep 20, 2023
CriticalFDA
Cardinal Health 200, Llc
Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
Medical Devices·457,200 affected·Sep 20, 2023
CriticalFDA
Cardinal Health 200, Llc
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
Medical Devices·3,084,300 affected·Sep 20, 2023
CriticalFDA
Cardinal Health 200, Llc
Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
Medical Devices·3,936,682 affected·Sep 20, 2023
High RiskFDA
Neurosync, Inc.
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tab...
Medical Devices·27 affected·Sep 19, 2023
High RiskFDA
Atrium Medical Corporation
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Medical Devices·48,339 affected·Sep 18, 2023
High RiskFDA
Nova Biomedical Corporation
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasm...
Medical Devices·161 affected·Sep 18, 2023
High RiskFDA
Atrium Medical Corporation
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, O...
Medical Devices·31,270 affected·Sep 18, 2023
High RiskFDA
Nova Biomedical Corporation
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1...
Medical Devices·1,779 affected·Sep 18, 2023
High RiskFDA
Atrium Medical Corporation
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-10...
Medical Devices·471,037 affected·Sep 18, 2023
CriticalFDA
Carefusion 303, Inc.
Alaris PCA Module 8120
Medical Devices·86,393 affected·Sep 15, 2023
CriticalFDA
Carefusion 303, Inc.
BD Alaris Syringe Module, REF 8110
Medical Devices·133,727 affected·Sep 15, 2023
High RiskFDA
Tornier, Inc
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Medical Devices·30 affected·Sep 15, 2023
High RiskFDA
Ge Healthcare
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Medical Devices·17 affected·Sep 14, 2023
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitor...
Medical Devices·45 affected·Sep 14, 2023
High RiskFDA
Ge Healthcare
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Medical Devices·329 affected·Sep 14, 2023
High RiskFDA
Cardinal Health 200, Llc
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Medical Devices·3 affected·Sep 13, 2023
High RiskFDA
Stryker Corporation
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Need...
Medical Devices·19 affected·Sep 13, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per car...
Medical Devices·342 affected·Sep 12, 2023
High RiskFDA
Olympus Corporation Of The Americas
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) ...
Medical Devices·2,496 affected·Sep 12, 2023
High RiskFDA
Raysearch Laboratories Ab
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical i...
Medical Devices·2 affected·Sep 12, 2023
High RiskFDA
Roi Cps Llc
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Medical Devices·103 affected·Sep 11, 2023
CriticalFDA
Eitan Medical Ltd
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Medical Devices·1,383 affected·Sep 11, 2023
High RiskFDA
Ge Healthcare
Universal Viewer Workflow Manager, Image processing radiological system
Medical Devices·57 affected·Sep 8, 2023
High RiskFDA
Ge Medical Systems China Co., Ltd.
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Medical Devices·1,638 affected·Sep 8, 2023
High RiskFDA
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Medical Devices·31 affected·Sep 8, 2023
High RiskFDA
Blue Belt Technologies, Inc
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Medical Devices·56 affected·Sep 7, 2023
High RiskFDA
Ge Medical Systems, Israel Ltd.
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imagi...
Medical Devices·5,986 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Medical Devices·0 affected·Sep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX BLUESTAR
Medical Devices·733 affected·Sep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis SYS, with CDX
Medical Devices·703 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Medical Devices·13 affected·Sep 6, 2023
High RiskFDA
Smiths Medical Asd Inc.
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Medical Devices·31,900 affected·Sep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Medical Devices·35 affected·Sep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Medical Devices·733 affected·Sep 6, 2023
High RiskFDA
Mazor Robotics Ltd
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Medical Devices·324 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
American Contract Systems, Inc.
LAVH, REF BBLV21C
Medical Devices·18 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack SAH, REF SAR530M
Medical Devices·96 affected·Sep 1, 2023