Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 93 of 548
FDA Devices Moderate Jan 17, 2024
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equi…
Olympus Corporation of the Americas
FDA Devices Moderate Jan 17, 2024
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Shirakawa Olympus Co., Ltd.
FDA Devices Moderate Jan 17, 2024
BD Recanalization System, REF: BDRECANSYSTEM
Bard Peripheral Vascular Inc
FDA Devices Moderate Jan 17, 2024
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part N…
Abiomed, Inc.
FDA Devices Moderate Jan 17, 2024
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM…
Baxter Healthcare Corporation
FDA Devices Moderate Jan 17, 2024
VADER pedicle system, torque wrench, Catalog Number 42-703
Icotec Ag
FDA Devices Moderate Jan 17, 2024
Model No. CYF-5, Cystonephrofiberscope
Shirakawa Olympus Co., Ltd.
FDA Drug Moderate Jan 10, 2024
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Dist…
Seaway Pharma Inc.
FDA Drug Moderate Jan 10, 2024
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A.…
Seaway Pharma Inc.
FDA Drug Moderate Jan 10, 2024
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distribu…
Seaway Pharma Inc.
FDA Devices Moderate Jan 10, 2024
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28…
Merit Medical Systems, Inc.
FDA Devices Critical Jan 10, 2024
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided …
Insulet Corporation
FDA Devices Critical Jan 10, 2024
Regard Dressing change kit, Item Number 800026006
ROi CPS LLC
FDA Devices Moderate Jan 10, 2024
Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Beaver Visitec International, Inc.
FDA Devices Moderate Jan 10, 2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medtronic Inc.
FDA Devices Critical Jan 10, 2024
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Busse Hospital Disposables, Inc.
FDA Devices Moderate Jan 10, 2024
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Encore Medical, LP
FDA Devices Moderate Jan 10, 2024
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Merit Medical Systems, Inc.
FDA Devices Moderate Jan 10, 2024
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Natus Medical Incorporated
FDA Devices Moderate Jan 10, 2024
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, …
Keystone Industries
FDA Devices Moderate Jan 10, 2024
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Natus Medical Incorporated
FDA Devices Moderate Jan 3, 2024
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Atrium Medical Corporation
FDA Devices Moderate Jan 3, 2024
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Landauer
FDA Devices Moderate Jan 3, 2024
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power …
Acumed LLC
FDA Devices Moderate Jan 3, 2024
Alinity ci-series System Control Module, REF: 03R70-01
Abbott Laboratories
FDA Devices Moderate Jan 3, 2024
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Medtronic Neuromodulation
FDA Devices Critical Jan 3, 2024
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheost…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Jan 3, 2024
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
DeRoyal Industries Inc
FDA Devices Moderate Jan 3, 2024
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofi…
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA Devices Moderate Jan 3, 2024
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Medtronic Neuromodulation
FDA Devices Critical Jan 3, 2024
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Megadyne Medical Products, Inc.
FDA Devices Moderate Jan 3, 2024
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofi…
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
FDA Devices Critical Jan 3, 2024
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Megadyne Medical Products, Inc.
FDA Devices Critical Dec 27, 2023
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Fresenius Kabi USA, LLC
FDA Devices Moderate Dec 27, 2023
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
CardioQuip, LLC
FDA Devices Moderate Dec 27, 2023
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Karl Storz Endoscopy
FDA Devices Moderate Dec 27, 2023
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
CardioQuip, LLC
FDA Devices Moderate Dec 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in …
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Dec 27, 2023
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
Karl Storz Endoscopy
FDA Devices Moderate Dec 27, 2023
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (J…
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Dec 27, 2023
Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: …
Karl Storz Endoscopy
FDA Devices Moderate Dec 27, 2023
AcuMatch Hip System, Catalog Number 142-32-27
Exactech, Inc.
FDA Devices Moderate Dec 27, 2023
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Pos…
Inpeco S.A.
FDA Devices Moderate Dec 27, 2023
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, …
Exactech, Inc.
FDA Devices Moderate Dec 27, 2023
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Karl Storz Endoscopy
FDA Devices Moderate Dec 27, 2023
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Physio-Control, Inc.
FDA Devices Critical Dec 27, 2023
AirTouch F20 Full Face Mask and User Guide
ResMed Ltd.
FDA Devices Moderate Dec 27, 2023
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320…
Exactech, Inc.
FDA Devices Critical Dec 27, 2023
AirTouch N20 Nasal Mask and User Guide
ResMed Ltd.