Medical Device Recalls

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect

Steris Corporation

Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias

Cook Biotech, Inc.

BD Pyxis MedBank MedPass Software, REF: 139088-01

CareFusion 303, Inc.

SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,

GE Medical Systems, LLC

CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Stay Safe Cap

Fresenius Medical Care Holdings, Inc.

DREAMTOME 44-30MM/260CM Material Number: M00584050

Boston Scientific Corporation

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Whe

Max Mobility LLC

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation

Exactech, Inc.

Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical sp

Siemens Healthcare Diagnostics, Inc.

Robotics Pack SAH, REF SAR530M

American Contract Systems, Inc.

Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

DePuy Orthopaedics, Inc.

Artis Q ceiling, Model Number 10848281

Siemens Medical Solutions USA, Inc

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement with

Stryker Corporation

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROB

MEDLINE INDUSTRIES, LP - Northfield

LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46

Linkbio Corp.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIAT

MEDLINE INDUSTRIES, LP - Northfield

Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE

Medline Industries, LP

Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

MEDLINE INDUSTRIES, LP - Northfield

125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 12

DeVilbiss Healthcare LLC

SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie M

Siemens Medical Solutions USA, Inc

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Magellan Diagnostics, Inc.

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation

DxM 1096 MicroScan WalkAway Instrument REF B1018-496

Beckman Coulter Inc.

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22

Merit Medical Systems, Inc.

Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Woodside Acquisitions Inc.

L9-3 Transducer Probe

Philips Ultrasound, Inc

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call

Hill-Rom Inc.