Medical Device Recalls

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100

Baxter Healthcare Corporation

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered

SURGIFY MEDICAL OY

Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: C

Olympus Corporation of the Americas

ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

Siemens Healthcare Diagnostics, Inc.

CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C

Townsend Design

Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product

Olympus Corporation of the Americas

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe

Dexcom, Inc.

The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein

Ortho-Clinical Diagnostics, Inc.

Model Number U225 VISIONIST CRT-P EL

Boston Scientific Corporation

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702

Hobbs Medical, Inc.

Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1

CooperVision, Inc.

Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

Stryker Orthopaedics

Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument

Nextremity Solutions

Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, p

SURGIFY MEDICAL OY

Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484

Baxter Healthcare Corporation

GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

Stryker Medical Division of Stryker Corporation

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Pr

Avanos Medical, Inc.

Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str

Visgeneer, Inc.

Intera 1.5T Achieva Nova Product Number: 781172;

Philips North America

Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

CareFusion 303, Inc.

Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSY

Medline Industries, LP

Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 11361

Biomet, Inc.

Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Inspire Medical Systems Inc.

Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or prev

Biomet, Inc.

Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powere

SURGIFY MEDICAL OY

RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040

Randox Laboratories Ltd.

HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.

Mckesson Medical-Surgical Inc. Corporate Office

NxTAG Respiratory Pathogen Panel, REF: I051C0447

Luminex Molecular Diagnostics Inc

DeRoyal BASIC EYE PACK, REF 89-9233.08

DeRoyal Industries Inc