Medical Device Recalls

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Mo

MEDLINE INDUSTRIES, LP - Northfield

X3 TRIATHLON CS INSERT NO 6 11 MM

Howmedica Osteonics Corp.

BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (

Becton Dickinson & Company

ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe

Baxter Healthcare Corporation

PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.50

Limacorporate S.p.A

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Ethicon, Inc.

Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment o

Sarnova HC, Llc

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

Microbiologics Inc

WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal acce

Boston Scientific Corporation

Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13

AVID Medical, Inc.

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

Katalyst Surgical, LLC

Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 5

Brius Technologies Inc.

Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determina

Roche Diagnostics Operations, Inc.

Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management

CHANGE HEALTHCARE CANADA COMPANY

FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

Envisiontec US Llc

MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta

Datascope Corp.

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Boston Scientific Corporation

PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approx

Ethicon, Inc.

iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

Conformis, Inc.

IDM-ARLITE-R. Electrical wheelchair component.

mo-Vis BVBA

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For

Cook Incorporated

Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A

Medline Industries, LP

INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040

PHASE SCIENTIFIC INTERNATIONAL LIMITED

Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Versi

Trinity Sterile, Inc.

Leica Microsystems M220 F12 Microscope Systems

Leica Microsystems, Inc.

Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06

AVID Medical, Inc.

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.

Staar Surgical Company

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13

RAYSEARCH LABORATORIES AB

LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

Fresenius Kabi USA, LLC