FDA Device Recalls

Class IIOngoing

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

Diagnostica Stago, Inc.

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

February 5, 2026 · DeviceView details →

Burlington Medical, Blockers.

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Burlington Medical, Thyroid Shield.

Burlington Medical, Caps.

Burlington Medical, Kilt

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System

Artegraft Vascular Graft; REF#: AG740;

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable

Artelon FlexBand Dynamic Matrix Ref: 31057

BD Kiestra" ReadA; Catalog No.: 446948.

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

Artelon FlexBand Plus Ref: 41054 & 41057

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR