Medical Device Recalls

NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and o

NeuMoDx Molecular Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000501;

Beaver Visitec International, Inc.

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis

Baxter Healthcare Corporation

All-round Joystick R-net Light. Electrical wheelchair component.

mo-Vis BVBA

Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

Biomet, Inc.

SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System

SoClean, Inc

Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitati

Beckman Coulter, Inc.

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Olympus Corporation of the Americas

Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid s

Integra LifeSciences Corp.

Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote

Abiomed, Inc.

Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

Preat Corp

Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (21

Medline Industries, LP

Dynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501

Mckesson Medical-Surgical Inc. Corporate Office

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Descr

Encore Medical, LP

VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072

Biomerieux Inc

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

Hobbs Helical Retrieval Basket Catalog Number: 4814

Hobbs Medical, Inc.

Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system

SEDECAL SA

Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain

The Metrix Company

a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgit

Mckesson Medical-Surgical Inc. Corporate Office

TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

Howmedica Osteonics Corp.

OxyMask O2 Adult REF OM-1125-14

Southmedic, Inc.

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CD

Medline Industries, LP

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

ROi CPS LLC

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump

ARROW INTERNATIONAL Inc.

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20

Becton Dickinson Infusion Therapy Systems, Inc.

Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time

Quidel Corporation

Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&

MEDLINE INDUSTRIES, LP - Northfield

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP

Covidien LP

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728

Philips North America Llc