Devices

Warning Letter — Happiest Baby, Inc.

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

Early Alert: Positive Pressure Breathing Device Issue from Baxter

Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers

B Braun Medical Inc — Class II: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Numb

B Braun Medical Inc — Class I: Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1,

Covidien LLC — Class II: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

Becton Dickinson & Company — Class I: BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacai

Draeger, Inc. — Class I: Atlan A350XL. Model Number: 8621600. anesthesia workstation

Early Alert: Breathing Circuit Set Issue from Hamilton Medical

Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective Ventilation When Used in Volume Control Ventilation (VCV) Mode

Early Alert: Infant Resuscitation System Issue from GE HealthCare

Early Alert: Insulin Pump Issue from Insulet

GE Medical Systems Information Technologies Inc — Class II: GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-

Medline Industries, LP — Class I: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as:

Abiomed, Inc. — Class I: Automated Impella Controller (AIC) with the below product descriptions and corresponding P

GE Medical Systems Information Technologies Inc — Class II: GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in con

UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

2024 Safety Communications

Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays Containing Bupivacaine Ampules

UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Early Alert: Catheter Introducer Kit Issue from Abiomed

MENTOR MEMORYGEL BREAST IMPLANT (MENTOR TEXAS) — Injury

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Malfunction

INSET II (UNOMEDICAL DEVICES S.A DE C.V) — Malfunction

COBALT¿ XT DR MRI SURESCAN¿ (MEDTRONIC EUROPE SARL) — Injury

Dexcom Uncovers Theft of Scrapped Product, Notifies Potentially Impacted Users

Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds

Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes

Becton, Dickinson and Company — Class II: Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Medtronic Perfusion Systems — Class II: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardi

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3

Medtronic Perfusion Systems — Class II: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Card

Medtronic Perfusion Systems — Class II: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardi

Medtronic Perfusion Systems — Class II: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; C

Early Alert: Heart Pump Issue from Abiomed

Early Alert: IV Tubing Set Issue from ICU Medical

Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers

Manifold Recall: Medline Removes Namic Star Off Handle Manifolds

Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets

Early Alert: Heart Pump Controller Issue from Abiomed

Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System

Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators

Medline Industries, LP — Class I: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-

GE Medical Systems, LLC — Class II: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

Stryker Sustainability Solutions — Class II: BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

MICROVENTION INC. — Class II: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length

DJO, LLC — Class II: Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424

Stryker Sustainability Solutions — Class II: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System

Early Alert: Anesthesia Machine Issue from Draeger, Inc.

Medline Industries, LP — Class II: See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Num

AVID Medical, Inc. — Class I: Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

Medline Industries, LP — Class II: Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

Medline Industries, LP — Class II: Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

DFI Co., Ltd. — Class II: One Step K in vitro diagnostic test REF: 81A4

Medline Industries, LP — Class II: Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK

Convenience Kit Recall: AVID Medical Removes Convenience Kits Containing Namic RA Syringes

Convenience Kit Recall: Aligned Medical Solutions Removes Convenience Kits Containing Namic RA Syringes

Convenience Kit Recall: American Contract Systems Removes Convenience Kits Containing Namic RA Syringes

Convenience Kit Recall: Medical Action Industries Removes Convenience Kits Containing Namic RA Syringes

Pacemaker Correction: Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps

Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication

Becton Dickinson & Co. — Class II: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

Medline Industries, LP — Class II: Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro

Medline Industries, LP — Class II: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.

Hologic, Inc — Class II: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Mo

Philips North America — Class II: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF

Boston Scientific Corporation — Class I: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P

Disruptions in Availability of Neurosurgical Patties, Sponges, and Strips - Letter to Health Care Providers

Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters

Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads

Trividia Health Correction for TRUE METRIX Blood Glucose Monitoring Systems

UNKNOWN XMTR (MEDTRONIC MINIMED) — Malfunction

PUMP MMT-1880L MM770G BLE MG (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Injury

ILET BIONIC PANCREAS (BETA BIONICS, INC.) — Malfunction

FREESTYLE LIBRE 3 PLUS (ABBOTT DIABETES CARE INC) — Malfunction

FREESTYLE LIBRE 2 PLUS (ABBOTT DIABETES CARE INC) — Malfunction

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM (DEXCOM, INC.) — Malfunction