Medical Device Recalls

Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.

ROi CPS LLC

Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rov

Micro-X Ltd.

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an

Boston Scientific Corporation

BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF

C.R. Bard Inc

TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B

American Contract Systems Inc

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/

ETHICON, LLC

SS 4.5MM Pellet Insertion Tray Catalog Number: B9807

Busse Hospital Disposables, Inc.

Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suc

Scientia Vascular, Inc.

Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system

SEDECAL SA

ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25

TEI Biosciences, Inc.

FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928

Full Vision Inc

DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab

DeRoyal Industries Inc

Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101

Invacare Corporation

Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical ch

Randox Laboratories Ltd.

CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU an

GE Healthcare, LLC

Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.

Olympus Corporation of the Americas

ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Descri

Alcon Research LLC

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate th

DKK Dai-Ichi Shomei Co., Ltd.

SOMATOM Drive with software syngo.CT VB20 Model #10431700

Siemens Medical Solutions USA, Inc

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Who

Accriva Diagnostics, Inc.

Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810)

Medtronic Neuromodulation

Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

C.R. Bard Inc

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog N

Siemens Healthcare Diagnostics, Inc.

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed t

Siemens Healthcare Diagnostics Inc

EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator

Medtronic Inc.

2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown

Tenderneeds Fertility LLC

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

Intersurgical Inc

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Howmedica Osteonics Corp.