Devices

Warning Letter — Koven Technologies, Inc.

AVID Medical, Inc. — Class II: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience ki

Medtronic MiniMed, Inc. — Class II: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

Boston Scientific Corporation — Class II: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into th

Penumbra, Inc. — Class II: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Boston Scientific Corporation — Class II: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percut

Alphatec Spine, Inc. — Class II: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

Orthofix U.S. LLC — Class II: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/

Boston Scientific Corporation — Class II: Rapid Refill Continuous Injection System, UPN M00566001

Abiomed, Inc. — Class I: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14

Papablic Inc — Class II: Papablic Replacement Brush Heads. Model Number: PAPA317AA.

Papablic Inc — Class II: Papablic Replacement Brush Heads. Model Number: Papablic18B

Abiomed, Inc. — Class I: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 1

Warning Letter — Linemaster Switch Corporation

Klowen Braces — Class II: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

CMR SURGICAL LIMITED — Class II: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Cat

ConvaTec, Inc — Class II: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Medtronic MiniMed, Inc. — Class II: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896

WALLAC OY — Class II: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used

Olympus Corporation of the Americas — Class II: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duoden

Warning Letter — ZIIP, Inc.

Warning Letter — Nihon Kohden Digital Health Solutions, LLC

Remel, Inc — Class II: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

Medline Industries, LP — Class II: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG

RAYSEARCH LABORATORIES AB — Class II: RayCare 2024A SP1. Oncology Information Systems.

Bard Access Systems, Inc. — Class II: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566

Medline Industries, LP — Class II: Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ9

Boston Scientific Corporation — Class II: CRE Pro Wireguided 12-15mm 240cm

Warning Letter — Skytron, LLC

Warning Letter — BlephEx, LLC

SURGIFY MEDICAL OY — Class II: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trep

Medline Industries, LP — Class II: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARAC

SURGIFY MEDICAL OY — Class II: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & acce

Zimmer, Inc. — Class II: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Cat

Dexcom, Inc. — Class II: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Ret

Ventec Life Systems, Inc. — Class II: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

MINIMED 720G OUS BLE CONNECT 3.0 MMOL/L (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Malfunction

SURGUARD2 SAFETY HYPODERMIC NEEDLE (TERUMO PHILIPPINES CORPORATION) — Malfunction

PUMP 1886 780G OUS BLE PUMP MG/DL (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Malfunction

CD HORIZON SOLERA 5.5/6.0 (MEDTRONIC SOFAMOR DANEK USA, INC.) — Malfunction

BIPAP S/T C SERIES (RESPIRONICS, INC.) — Malfunction

Warning Letter — 3B Medical, Inc. dba Reach Health, Inc.

Warning Letter — BMC Medical Co., Ltd.

Warning Letter — AseptiKits, LLC

Medline Industries, LP — Class II: MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ673

Medline Industries, LP — Class II: MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU

Medtronic Navigation, Inc.-Boxborough — Class II: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Medline Industries, LP — Class II: MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG,

Inspire Medical Systems Inc. — Class II: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/C

ARROW INTERNATIONAL, LLC — Class I: Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X

INSPIREMD Inc — Class II: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND

Avanos Medical, Inc. — Class II: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320

GE Medical Systems, LLC — Class II: Allia IGS 3 Pulse angiographic X-ray system

Avanos Medical, Inc. — Class II: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Mod

Fresenius Medical Care Holdings, Inc. — Class II: Bicarby Dialysate; Model number: RFP-400-G;

Avanos Medical, Inc. — Class II: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320

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