Medical Devices Recalls

Focusee Recalls Tideway Hair Dryers Due to Electrocution or Shock Hazard

MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP S…

Siemens Medical Solutions USA, Inc

Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid…

Roche Diabetes Care, Inc.

Baseus Magnetic Wireless Charging Power Banks Recalled Due to Fire Hazard; Imported by Shenzhen Baseus Technology

Daikin Comfort Technologies Manufacturing Recalls Daikin FIT, Amana Brand S-series, and Goodman SD Heat Pumps Due to Risk of Excessive Heat Exposure

Daikin Comfort Technologies Manufacturing L.P., of Houston, Texas

Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure …

Baxter Healthcare Corporation

PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tis…

Ethicon, Inc.

MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated…

Ethicon, Inc.

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but no…

Ethicon, Inc.

OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

Exactech, Inc.

OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38…

Exactech, Inc.

Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910

Howmedica Osteonics Corp.

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsur…

Ethicon, Inc.

ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part Number…

ZOLL Medical Corporation

VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, c…

Ethicon, Inc.

HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

Howmedica Osteonics Corp.

Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227

Beaver Visitec International, Inc.

Head Rush Technologies Recalls TRUBLUE iQ Auto Belay Devices Due to Fall Hazard

Head Rush Technologies, of Louisville, Colorado

myCharge Recalls POWER HUB All-In-One Portable Chargers Due to Fire and Burn Hazards; Sold Exclusively at Costco

Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

Wondfo USA Co Ltd

Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Di…

Wondfo USA Co Ltd

OMTech Desktop Laser Engraver

Rygel Advanced Machines d/b/a Omtech Laser

Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep…

Wondfo USA Co Ltd

Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

B Braun Medical Inc

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

Covidien, LLC

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO…

Avanos Medical, Inc.

Aeos Robotic Digital Microscope, Product Code: PV010

Aesculap Inc

Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog…

Mckesson Medical-Surgical Inc. Corporate Office

MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (ME…

Canon Medical System, USA, INC.

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO…

Avanos Medical, Inc.

CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundarie…

Blue Belt Technologies, Inc

Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step …

Wondfo USA Co Ltd

Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

B Braun Medical Inc

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Young Dental Manufacturing I, LLC

Daikin Comfort Technologies Manufacturing Recalls Amana, Daikin, Goodman-Branded Air Conditioning and Heat Pump Packaged Units Due to Fire Hazard

Daikin Comfort Technologies Manufacturing L.P. (f/k/a Goodman Manufacturing Company L.P.), of Houston, Texas

The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diam…

Stryker Neurovascular

ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020

MEDLINE INDUSTRIES, LP - Northfield

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

Philips North America Llc

ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.

Newport Corp

ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record …

Nihon Kohden America Inc

ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

ARROW INTERNATIONAL Inc.

FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000

Medtronic Navigation, Inc.-Littleton