Medical Device Recalls

Design Options¿ / Epidural anesthesia kit (10 count carton)

B. Braun Medical, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter

Boston Scientific Corporation

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi USA, LLC

Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292

Cardinal Health 200, LLC

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K

Merit Medical Systems, Inc.

Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabi

ZOLL Circulation, Inc.

Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mo

Prismatik Dentalcraft, Inc.

Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective feature

Trackx Technology Inc

PACK GENERAL ROBOTIC. Medical convenience kit.

AVID Medical, Inc.

Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP,

Medline Industries, LP

Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Inspire Medical Systems Inc.

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Boston Scientific Corporation

Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYN

MEDLINE INDUSTRIES, LP - Northfield

Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;

DAYE (ANNE'S DAY LTD)

3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape

3M Healthcare Business

Synaptive Trackable Suction Set Standard and Malleable

Synaptive Medical Inc

ECHELON MRI System

Hitachi Healthcare Americas Corporation

ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators

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

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N

Smiths Medical ASD Inc.

CURAD STRNG WATRPRF STRIP 1IN 20CT, SKU

Family Dollar Stores, Llc.

Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

Cellex

Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03

Onkos Surgical, Inc.

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

Medline Industries, LP

PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL,

Entopsis , Inc.

SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

C.R. Bard Inc

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

GE Medical Systems, LLC

Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of

Baxter Healthcare Corporation

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Civco Medical Instruments Co. Inc.

LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022

Physio-Control, Inc.

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC

Cordis US Corp