Medical Device Recalls

Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both

Tandem Diabetes Care, Inc.

BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

Maquet Medical Systems USA

Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version

C-RAD POSITIONING AB

COVID Test Kit Nonsterile

American Contract Systems, Inc.

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: I

Smiths Medical ASD Inc.

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W

Augustine Temperature Management, LLC

Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous a

Wolf, Henke Sass, Gmbh

epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by tra

Siemens Healthcare Diagnostics, Inc.

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product

Electro Medical Systems SA

Aligned Medical AMS16835 Fluids Kit RX

Windstone Medical Packaging, Inc.

Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

Covidien, LLC

Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

Pivotal Health Solutions, Inc.

Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system

GE Medical Systems, LLC

Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1

MEDLINE INDUSTRIES, LP - Northfield

Automated Impella Controller (AIC); Product Code: 0042-0000-US;

Abiomed, Inc.

Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic

ENDOMAGNETICS LTD

Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Numb

MEDLINE INDUSTRIES, LP - Northfield

PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B023165

Medicrea International

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

Luminex Corporation

Model Number L100, ESSENTIO SR SL Pacemaker

Boston Scientific Corporation

ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators

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

Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCN

American Contract Systems Inc.

TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter

GE Healthcare Finland Oy

epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by

Siemens Healthcare Diagnostics, Inc.

Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

Atrium Medical Corporation

Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are

Cook Incorporated

First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

First Source Inc

Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 153

ETAC A/S

Legacy Base for Dual Bed Configurations

Craftmatic Industries, Inc.

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

Olympus Corporation of the Americas