Open, ClassifiedPosted Jul 17, 2026·Initiated Jun 11, 2026
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Reason: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include
FARAPOINT PFA catheter information.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationDistribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.Recall #Z-2751-2026 Open, ClassifiedPosted Jul 17, 2026·Initiated Jun 11, 2026
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Reason: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include
FARAPOINT PFA catheter information.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationDistribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.Recall #Z-2752-2026 Open, ClassifiedPosted Jul 17, 2026·Initiated Jun 11, 2026
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Reason: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Root cause: Under Investigation by firm
Recalling firm: Boston Scientific CorporationType: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationDistribution: International distribution in the countries of Italy, Austria, France, Germany, Belgium.Recall #Z-2753-2026 Open, ClassifiedPosted Jul 17, 2026·Initiated Jun 17, 2026
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Reason: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Root cause: Under Investigation by firm
Recalling firm: Paragon 28, Inc.Type: Passer, Wire, OrthopedicDistribution: US nationwide, Australia, Canada, The Netherlands, and New ZealandRecall #Z-2758-2026
Open, ClassifiedPosted Jul 17, 2026·Initiated Jun 24, 2026
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
Reason: ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
Root cause: Process control
Recalling firm: ICU Medical Inc.Type: Warmer, Thermal, Infusion FluidDistribution: Worldwide - US Nationwide distribution.Recall #Z-2759-2026
Open, ClassifiedPosted Jul 17, 2026·Initiated Jun 19, 2026
Power F2 Powered Fastening System, Product No. 0567091
Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance.
Item no. 0567091
Reason: Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.
Root cause: Process control
Recalling firm: Ferno-Washington IncType: Stretcher, WheeledDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, GA, IA, ID, IL, IN, KY, LA, MD, ME, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Poland, Netherlands, Canada, Germany, Norway, United Kingdom, Denmark and New Zealand.Recall #Z-2760-2026 Open, ClassifiedPosted Jul 16, 2026·Initiated Jun 12, 2026
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
Reason: The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
Root cause: Component design/selection
Recalling firm: Tosoh Bioscience IncType: Radioimmunoassay, Testosterones And DihydrotestosteroneDistribution: Global Distribution. US Nationwide.Recall #Z-2746-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated May 21, 2026
Papablic Replacement Brush Heads. Model Number: Papablic18B
Reason: Potential for brush heads to break.
Root cause: Device Design
Recalling firm: Papablic IncType: Toothbrush, PoweredDistribution: US Nationwide distribution.Recall #Z-2733-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated May 21, 2026
Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Reason: Potential for brush heads to break.
Root cause: Device Design
Recalling firm: Papablic IncType: Toothbrush, PoweredDistribution: US Nationwide distribution.Recall #Z-2734-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated Jun 10, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas
TOTAL KNEE PACK
DYNJT6267
Reason: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution in the states of CA and UT.Recall #Z-2736-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated Jun 10, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas
TOTAL KNEE PACK-LF
DYNJ61651J
Reason: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US Nationwide distribution in the states of CA and UT.Recall #Z-2737-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated May 25, 2026
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Root cause: Packaging
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.Recall #Z-2738-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated May 25, 2026
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Root cause: Packaging
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.Recall #Z-2739-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated Jun 15, 2023
Brand Name: Rio" II
Product Name: Rio" II Nasal Pillows Interface
Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)
Software Version: N/A
Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear.
Component: No
Reason: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Root cause: Labeling Change Control
Recalling firm: 3B Medical, Inc.Type: Ventilator, Non-Continuous (Respirator)Distribution: US Nationwide distribution.Recall #Z-2740-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated Jun 2, 2026
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI
00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Reason: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Root cause: Under Investigation by firm
Recalling firm: Maquet Cardiovascular, LLCType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.Recall #Z-2741-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated Mar 5, 2026
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Root cause: Software Design Change
Recalling firm: Daavlin Distributing CompanyType: Light, Ultraviolet, DermatologicalDistribution: US Nationwide distribution.Recall #Z-2742-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated Mar 5, 2026
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Root cause: Software Design Change
Recalling firm: Daavlin Distributing CompanyType: Light, Ultraviolet, DermatologicalDistribution: US Nationwide distribution.Recall #Z-2743-2026
Open, ClassifiedPosted Jul 15, 2026·Initiated Mar 5, 2026
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Root cause: Software Design Change
Recalling firm: Daavlin Distributing CompanyType: Light, Ultraviolet, DermatologicalDistribution: US Nationwide distribution.Recall #Z-2744-2026
Open, ClassifiedPosted Jul 14, 2026·Initiated Jun 10, 2026
Orthofix MINIRAIL, STANDARD LENGTHENER
Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Root cause: Process change control
Recalling firm: Orthofix U.S. LLCType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI
OUS: NoneRecall #Z-2729-2026
Open, ClassifiedPosted Jul 14, 2026·Initiated Jun 10, 2026
Orthofix MINIRAIL, SHORT, LENGTHENER
REF: M103, Unilateral orthopedic/trauma external fixation device
Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Root cause: Process change control
Recalling firm: Orthofix U.S. LLCType: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentDistribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI
OUS: NoneRecall #Z-2730-2026