Medical Device Recalls

Welch Allyn Connex Spot Monitor

Baxter Healthcare Corporation

HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of O

Boston Scientific Corporation

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ8034

Medline Industries, LP

TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324

Howmedica Osteonics Corp.

Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

Beckman Coulter Inc.

Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Prod

Angiodynamics, Inc.

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro

Smiths Medical ASD Inc.

VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

Civco Medical Instruments Co. Inc.

Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

MEDLINE INDUSTRIES, LP - Northfield

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TR

Medline Industries, LP

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201

Philips Ultrasound, LLC

SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spac

B Braun Medical Inc

SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in pro

Integra LifeSciences Corp.

ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.

Stryker Medical Division of Stryker Corporation

Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

Mobius Imaging, LLC

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/

Medline Industries, LP

Brand Name: Leksell Vantage Arc System REF: 1053958

Elekta, Inc.

X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. C

X-NAV Technologies, LLC

IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

Randox Laboratories Ltd.

SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain

The Metrix Company

CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.

Smiths Medical ASD, Inc.

Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator

Hamilton Medical, Inc.

Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. Fo

Surgical Innovations Ltd

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump

ARROW INTERNATIONAL Inc.

Model Number L221 PROPONENT DR EL Pacemaker

Boston Scientific Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;

Beaver Visitec International, Inc.

MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

Medacta Usa Inc

MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK,

Medline Industries, LP

Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize

Tandem Diabetes Care, Inc.