Medical Device Recalls

AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

Siemens Medical Solutions USA, Inc

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035

TELEFLEX LLC

Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet &

Microtek Medical Inc.

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

Altruan GmbH

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter

Boston Scientific Corporation

Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/

Aesculap Inc

Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software

B Braun Medical Inc

4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4

Daavlin Distributing Company

8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049

Intuitive Surgical, Inc.

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDI

Medline Industries, LP

GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

GE Medical Systems China Co., Ltd.

Achieva XR Product Numbers: (1) 781153, (2) 781253;

Philips North America

Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SE

Landauer

GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.

GE Medical Systems China Co., Ltd.

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

Fresenius Kabi USA, LLC

Epidural Tray Catalog 1577

Busse Hospital Disposables, Inc.

MEDLINE ANTERIOR HIP PACK DYNJ64672B

Medline Industries, LP

Rumex Disposable Diamond Dusted ILM Elevator, 12-7523

Vortex Surgical Inc.

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Aesculap Implant Systems LLC

WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

Boston Scientific Corporation

Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03

Getinge Usa Sales Inc

MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597

Medline Industries, LP

FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

Migo Trading LLC

Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI cod

Abbott Medical

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, M

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HA

Olympus Corporation of the Americas

Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

St. Jude Medical, Cardiac Rhythm Management Division

Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KEL

MEDLINE INDUSTRIES, LP - Northfield

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surge

DePuy Orthopaedics, Inc.

EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF:

Encore Medical, LP