Recalls in New Hampshire (page 25)
3892 recalls.
- Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) HYSTEROSCOPY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) C-SECTION PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See full list in RES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) OB KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) NEURO SHUNT- CODMAN recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ADMIT KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PPE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CVC PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LITHOTOMY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DYNDA3003 recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC LINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) SCC RF PAIN MGMT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANCILLARY PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - One Step P in vitro diagnostic test REF: 8194 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step K in vitro diagnostic test REF: 81A4 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - Uric Acid in vitro diagnostic test REF: 31H0P recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step pH in vitro diagnostic test REF: 31I4P recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step UTI in vitro diagnostic test REF: 3374 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step 10A in vitro diagnostic test recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported May 13, 2026 · Respiratory/sore throat panel test may result in false negative results and control failures. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining... - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - Mint Lesion recall (Mint Medical GmbH)
Medical deviceClass IIReported May 13, 2026 · If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be... - BioFire Joint Infection recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported May 13, 2026 · Contamination to in-vitro diagnostic test may result in false positives. - LIFEPAK 15 recall (Physio-Control, Inc.)
Medical deviceClass IIReported May 13, 2026 · Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was... - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module ... recall (Spacelabs Healthcare, Inc.)
Medical deviceClass IIReported May 13, 2026 · Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). - Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical... recall (Centinel Spine, Inc.)
Medical deviceClass IIReported May 13, 2026 · Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was... - Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc... recall (Centinel Spine, Inc.)
Medical deviceClass IIReported May 13, 2026 · Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was... - LUX-Dx II Plus recall (Boston Scientific Corporation)
Medical deviceClass IIReported May 13, 2026 · For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or... - LUX-DX II recall (Boston Scientific Corporation)
Medical deviceClass IIReported May 13, 2026 · For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or... - Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 ... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 ... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - EVLWZL and Gunugu Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violates Mandatory Standard for Mattress Flammability
Consumer productReported May 7, 2026 · The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - Allura Imports Recalls Youth Sweatshirts with Bobcat Logo and Drawstrings Due to Risk of Serious Injury or Death from Strangulation Hazard; Violates Federal Regulations for Children's Upper Outerwear
Consumer productReported May 7, 2026 · The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children from strangulation. The sweatshirts are in... - Analemma Water Bottles Recalled Due to Risk of Serious Injury or Death from Laceration and Ingestion Hazards; Imported by New Earth Technologies d.o.o.
Consumer productReported May 7, 2026 · The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards. - Rainbow Wall Toys Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Violate Mandatory Standard for Children's Toys; Sold on Amazon by Justforjoyful
Consumer productReported May 7, 2026 · The recalled toys violate the mandatory safety standard for children's toys because the drumstick that is attached to the xylophone component has a spherical... - Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold on Temu by Foubeaka and Geniuss
Consumer productReported May 7, 2026 · The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and... - Natural Pigments Recalls Rublev Colours Gum Turpentine and Mineral Spirits Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
Consumer productReported May 7, 2026 · The gum turpentine and mineral spirits contain turpentine and low-viscosity hydrocarbons, respectively, which must be in child-resistant packaging, as required... - Svnntaa Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation Hazards; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Eokeanon
Consumer productReported May 7, 2026 · The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed... - Favoto Bicycle Helmets Recalled Due to Risk of Serious Head Injury; Violate Mandatory Standard for Bicycle Helmets; Sold on Amazon by Favoto
Consumer productReported May 7, 2026 · The recalled helmets violate the mandatory safety standard for bicycle helmets because they do not comply with the positional stability, labeling and... - ZMC Group Recalls Multiple Light Up Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported May 7, 2026 · The recalled toys violate the mandatory safety standard for children's toys because the toy contains button cell batteries that can be easily accessed by... - EEMB USA Recalls Battery Pouches Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries
Consumer productReported May 7, 2026 · The lithium coin batteries are in pouches that are not child-resistant as required under Reese's Law. If a child swallows button cell or coin batteries, the... - Brand Name: Leksell Vantage Arc System REF: 1053958 recall (Elekta, Inc.)
Medical deviceClass IIReported May 6, 2026 · Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. - Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak ... recall (Advanced Bionics, LLC)
Medical deviceClass IIReported May 6, 2026 · The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the... - Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery... recall (Clinical Innovations, LLC)
Medical deviceClass IIReported May 6, 2026 · Due to complaints of device breakage at the traction force gauge to handle joint. - Calypso Tropic Tango Lemonade. 16 FL oz recall (King Juice Company, Inc.)
FoodClass IIReported May 6, 2026 · Product contains undeclared Yellow No. 5. - My Mochi Strawberry flavored Non-Dairy Frozen Dessert recall (The Mochi Ice Cream Company, LLC)
FoodClass IIReported May 6, 2026 · Foreign object found inside retail container. - Alendronate Sodium Oral Solution recall (Hikma Pharmaceuticals USA INC)
DrugClass IIReported May 6, 2026 · This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. - Lidocaine Wound Gel recall (Water-Jel Technologies, LLC)
DrugClass IIIReported May 6, 2026 · Failed PH Specifications - fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Ketamine Hydrochloride Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Phenylephrine Hydrochloride Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Similasan recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - iVIZIA recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - Optase Dry Eye Intense Drops recall (SCOPE HEALTH)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility - Levocarnitine Injection recall (American Regent, Inc.)
DrugClass IIIReported May 6, 2026 · Labeling: Missing Label - GenTeal Tears recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Systane recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline or Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - epoc BGEM BUN Test Card recall (Siemens Healthcare Diagnostics Inc)
Medical deviceClass IIReported May 6, 2026 · Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial... - Philips Bridge Prep Kit REF: K12-09098C Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire