Medical Device Recalls

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a cons

Stryker Corporation

CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e

GE Healthcare Finland Oy

SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140

TELEFLEX LLC

ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS1

ConMed Corporation

smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

Smiths Medical ASD Inc.

Clean Catch Kit, SKU DYKM1833A; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101

Happiest Baby, Inc

Wisp and Wisp Youth Nasal Mask

Philips Respironics, Inc.

Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PI

MEDLINE INDUSTRIES, LP - Northfield

Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN

Medline Industries, LP

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

BioFire Diagnostics, LLC

First SIGN SARS-CoV-2 Antigen Test

WHPM Inc.

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-3

Micro Therapeutics, Inc.

MEDLINE OPEN HEART, REF DYNJ904261B

MEDLINE INDUSTRIES, LP - Northfield

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21

American Contract Systems, Inc.

Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile su

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack

MEDLINE INDUSTRIES, LP - Northfield

epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by tra

Siemens Healthcare Diagnostics, Inc.

BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9

CareFusion 303, Inc.

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins

Olympus Corporation of the Americas

Artis zee biplane MN, Model Number 10094143

Siemens Medical Solutions USA, Inc

Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017

Cook Incorporated

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Produc

Intuitive Surgical, Inc.

Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis,

Covidien Llc

WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten

Boston Scientific Corporation

1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System

GE Healthcare, LLC

BD Pyxis Mini Main REF: 349 Medication cabinet

CareFusion 303, Inc.