Medical Devices Recalls

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Anal…

Beckman Coulter Inc.

IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF…

S.I.N. Implant System Ltda

Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dissolved Oxygen Test Kits Recalled Due to Risk of Serious Injury or Death from Poisoning to Young Children; Violates Mandatory Standard for Child-Re…

Ningbo Leha E-Commerce Co., Ltd., of China doing business as Amazon seller Almpal

Zyntony Recalls Kogalla Power Banks Due to Fire and Burn Hazards; Sold on Kogalla.com

Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; …

Baxter Healthcare Corporation

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

Tandem Diabetes Care, Inc.

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K1628…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379…

MEDLINE INDUSTRIES, LP - Northfield

Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-60…

Maquet Cardiovascular, LLC

Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Produ…

Abiomed, Inc.

Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

Stryker Communications

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

Philips North America Llc

Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

Philips North America Llc

Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinna…

ORTOMA AB

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. …

Philips North America Llc

Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

Philips North America Llc

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer t…

CooperVision, Inc.

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

Philips North America Llc

Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. …

Philips North America Llc

Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

Biomet, Inc.

FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmA…

Biofire Defense

Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA0…

Mindray DS USA, Inc. dba Mindray North America

Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728…

Philips North America Llc

Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone…

CooperVision, Inc.

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3…

Philips North America Llc

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

Boston Scientific Corporation

Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532…

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not app…

Agilent Technologies Denmark ApS

i-STAT EG6+ cartridge. List Number: 03P77-25.

Abbott Point Of Care Inc.

3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370

3M Company

Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist componen…

Max Mobility LLC

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

Folsom Metal Products, Inc.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm r…

BigTree Sales Inc.

i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Abbott Point Of Care Inc.

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Beckman Coulter Inc.

SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

C.R. Bard Inc

SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

C.R. Bard Inc