Devices

Medline Industries, LP — Class II: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)

Cardinal Health 200, LLC — Class II: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)

AVID Medical, Inc. — Class II: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (k

Fresenius Medical Care Renal Therapies Group, LLC — Class II: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Diagnostica Stago, Inc. — Class II: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitativ

Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) N

IMRIS Imaging Inc — Class II: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned,

Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54

Medline Industries, LP — Class II: Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Me

Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U;

IMRIS Imaging Inc — Class II: ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000

Vanta (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Injury

STRATAFIX Symmetric PDS Plus (Ethicon Inc.) — Injury

FreeStyle Libre 2 (Abbott Diabetes Care Inc) — Malfunction

MiniMed 780G US System BLE Connect 3.0 mg/dL (Medtronic Puerto Rico Operations Co.) — Malfunction

HeartStart MRx monitor/defib (Philips North America LLC) — Malfunction

Covidien, LP — Class II: V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4

Medline Industries, LP — Class II: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Numbe

W L Gore & Associates, Inc. — Class II: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expandi

MICROVENTION INC. — Class II: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US

Cardinal Health 200, LLC — Class II: Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726

Cardinal Health 200, LLC — Class II: Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30S

Warning Letter — Nipro Renal Solutions USA, Corporation

Siemens Healthcare Diagnostics, Inc. — Class III: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No

Oxos Medical Inc — Class II: Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Numb

United Orthopedic Corp. — Class II: Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Mo

INTEGRATED MEDCRAFT LLC — Class II: FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. C

Siemens Healthcare Diagnostics, Inc. — Class II: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

GE Medical Systems Information Technologies Inc — Class II: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

Windstone Medical Packaging, Inc. — Class II: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pac

Instrumentation Laboratory — Class II: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 000240

Windstone Medical Packaging, Inc. — Class II: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray

Stryker GmbH — Class II: Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.

Medtronic Perfusion Systems — Class II: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmon

Stryker GmbH — Class II: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.

Warning Letter — Koven Technologies, Inc.

CLEARLINK/CONTINU-FLO/DUO-VENT (BAXTER HEALTHCARE CORPORATION) — Injury

Sentus ProMRI OTW QP L-85/49 (Biotronik SE & Co. KG) — Injury

CapSure Fix MRI (Medtronic Puerto Rico Villalba) — Malfunction

AIA-360 (Tosoh Hi-Tec, Inc.) — Malfunction

CapSureFix Novus Lead MRI SureScan (Medtronic Puerto Rico Villalba) — Malfunction

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