Medical Device Recalls

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC

Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu

Bard Peripheral Vascular Inc

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter

Boston Scientific Corporation

American Contract Systems Hand Pack convenience kit

American Contract Systems, Inc.

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicat

Zimmer, Inc.

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.

Baxter Healthcare Corporation

HYDRATOME RX 49-30MM/260CM Material Number: M00583010

Boston Scientific Corporation

McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS

Zhejiang Kindly Medical Devices Co., Ltd.

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Tornier, Inc

Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion

B. Braun Medical, Inc.

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Siemens Medical Solutions USA, Inc

Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440

Medline Industries, LP

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focu

B-K Medical A/S

smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur

Smith & Nephew Inc

Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36

SunMed Holdings, LLC

Puritan Bennett Cuff Pressure Manager, REF: 180-03

Covidien

8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of proced

Intuitive Surgical, Inc.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an

Boston Scientific Corporation

Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584404;

Beaver Visitec International, Inc.

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

FUJIFILM Healthcare Americas Corporation

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

Fresenius Medical Care Holdings, Inc.

Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator

GE Hangwei Medical Systems, Co. LTD

Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Applic

Boston Scientific Corporation

Flow-i C30 Anesthesia System, model 6677300

Getinge Usa Sales Inc

System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allur

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

DePuy Orthopaedics, Inc.

KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy