Recalls in Florida (page 24)
4115 recalls.
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection recall (Medline Industries, LP)
Medical deviceClass IReported June 3, 2026 · Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues... - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection recall (Medline Industries, LP)
Medical deviceClass IReported June 3, 2026 · Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues... - Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection recall (Medline Industries, LP)
Medical deviceClass IReported June 3, 2026 · Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues... - Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 recall (O&M HALYARD INC)
Medical deviceClass IIReported June 3, 2026 · Nitrile Exam Glove failed to meet specifications chemical permeation performance. - Walmart Recalls Mainstays 9-Drawer Fabric Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units
Consumer productReported May 28, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or... - Luminous Fidget Spinner Balls Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Anzmtosn
Consumer productReported May 28, 2026 · The recalled toys violate the mandatory safety standard for toys because the mini flashlight included with the fidget spinner balls contains button cell... - Missry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported May 28, 2026 · The racket sets violate the mandatory standard for toys because the screw on the racket used to secure the battery compartment does not remain attached when... - Joy Furniture Recalls Talan and Royce Living Room Furniture Sets Due to Risk of Serious Injury from a Fire Hazard
Consumer productReported May 28, 2026 · The power switch on the sofa, loveseat, or recliner can malfunction and overheat posing a risk of serious injury from a fire hazard. - Giantex Recalls Lounge Chairs Due to Amputation Hazard
Consumer productReported May 28, 2026 · Consumers can place their fingers in a pinch point, when adjusting the lounge chair, posing an amputation risk. - Tzumi Electronics Recalls SLF Sauna Blankets Due to Fire and Burn Hazards
Consumer productReported May 28, 2026 · The recalled sauna blankets can overheat, posing fire and burn hazards. - Lithium Coin Batteries Recalled Due to Battery Ingestion; Violates Federal Statute for Child-Resistant Packaging of Coin Batteries; Imported by Proudly American Store, of Canada
Consumer productReported May 28, 2026 · The recalled coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. When button cell or coin... - Daoen Recalls Zen Magnetic Promotional Ball Sets Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys
Consumer productReported May 28, 2026 · The recalled magnetic balls violate the mandatory standard for toys because they are loose high-powered magnets, posing an ingestion hazard to children. When... - MiniWarGaming and Primal Horizon Disc Magnets Recalled Due to Risk of Serious Injury or Death from Ingestion; Violate Mandatory Standard for Magnets; Imported by MiniWarGaming
Consumer productReported May 28, 2026 · The magnets violate the mandatory safety standard for magnets because the high-powered magnets fit within CPSC's small parts cylinder and are stronger than... - Giantex Recalls Giantex and Costway Portable Steam Saunas Due to Burn Hazard
Consumer productReported May 28, 2026 · The sauna's steam diffuser can be positioned too close to a consumer's body, allowing hot steam to come in contact with user, posing a burn hazard. - GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI PREMIUM HOT COCOA MIX recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI SWEET GROUND POWDER CHOCOLATE & COCOA recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI SWEET GROUND POWDER WHITE CHOCOLATE FLAVORED recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX VANILLA recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX WHITE MOCHA recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX MOCHA recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX FROZEN HOT COCOA recall (Ghirardelli Chocolate Company)
FoodClass IReported May 27, 2026 · Potential contamination with Salmonella. - Pork King Good Onion & Sour Cream Seasoning. Net Wt. 3 oz recall (Pork King Good, LLC)
FoodClass IReported May 27, 2026 · Seasoning was made with recalled California Dairies milk powder due to Salmonella contamination. - Vitamin B-Complex recall (Llorens Pharmaceuticals International Division, Inc.)
FoodClass IIReported May 27, 2026 · Foreign object: black particulate matter - Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 ... recall (C.R. Bard Inc)
Medical deviceClass IIReported May 27, 2026 · Due to stain present on the surface of affected foley catheters. - OneLIF Interbody Cage recall (Novapproach Spine, LLC)
Medical deviceClass IIReported May 27, 2026 · Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the... - Oncology Kit w/60" recall (ICU Medical, Inc.)
Medical deviceClass IIReported May 27, 2026 · Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak... - Swan-Ganz Pacing Catheter recall (Becton, Dickinson and Company)
Medical deviceClass IIReported May 27, 2026 · Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection... - Swan-Ganz Jr Catheter recall (Becton, Dickinson and Company)
Medical deviceClass IIReported May 27, 2026 · Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection... - Swan-Ganz Catheter recall (Becton, Dickinson and Company)
Medical deviceClass IIReported May 27, 2026 · Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection... - Fisher Tex Mex Trail Mix 30 oz plastic jar recall (JOHN B SANFILIPPO & SONS INC)
FoodClass IReported May 27, 2026 · potential presence of Salmonella - Good & Gather Mexican Street Corn Trail Mix 8 oz bag recall (JOHN B SANFILIPPO & SONS INC)
FoodClass IReported May 27, 2026 · potential presence of Salmonella - Squirrel Brand Town & Country Mix 16 oz can recall (JOHN B SANFILIPPO & SONS INC)
FoodClass IReported May 27, 2026 · potential presence of Salmonella - Squirrel Brand Travelers Mix 16 oz can recall (JOHN B SANFILIPPO & SONS INC)
FoodClass IReported May 27, 2026 · potential presence of Salmonella - Southern Style Nuts Hunter Mix 30 oz plastic jar recall (JOHN B SANFILIPPO & SONS INC)
FoodClass IReported May 27, 2026 · potential presence of Salmonella - Southern Style Nuts Gourmet Hunter Mix 23 oz plastic jar recall (JOHN B SANFILIPPO & SONS INC)
FoodClass IReported May 27, 2026 · potential presence of Salmonella - Non Fat Dry Milk 1# recall (PS Seasoning & Spices, Inc.)
FoodClass IReported May 27, 2026 · Product was made with milk powder recalled by the supplier due to Salmonella contamination. - PSW21585 Save A Lot Bind 50# recall (PS Seasoning & Spices, Inc.)
FoodClass IReported May 27, 2026 · Product was made with milk powder recalled by the supplier due to Salmonella contamination. - Blackstone Parmesan Ranch Seasoning recall (PS Seasoning & Spices, Inc.)
FoodClass IReported May 27, 2026 · Product was made with milk powder recalled by the supplier due to Salmonella contamination. - 1P Jalapeno Heat Unit for 300 lbs of Meat recall (PS Seasoning & Spices, Inc.)
FoodClass IReported May 27, 2026 · Product was made with milk powder recalled by the supplier due to Salmonella contamination. - 1P Original Smokehouse Unit for 300 lbs. of Meat recall (PS Seasoning & Spices, Inc.)
FoodClass IReported May 27, 2026 · Product was made with milk powder recalled by the supplier due to Salmonella contamination. - Ellsworth Sour Cream + Onion Seasoning recall (PS Seasoning & Spices, Inc.)
FoodClass IReported May 27, 2026 · Product was made with milk powder recalled by the supplier due to Salmonella contamination. - Liposomal Sleep Spray. Dosage: 6 sprays Liquid. Packaging: Aluminum bottle. 30 ml.... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal D3+B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml.... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal D3-5000IU Spray Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml.... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Prenatal+Postnatal Liquid Multivitamin Drops - Iron Free. Dosage: 3mL... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Women's Liquid Multivitamin Drops - Iron Free. Dosage: 3ml Liquid.... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Kids Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Collagen Booster. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml.... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Women's Liquid Multivitamin Drops with Iron. Dosage: 3mL Liquid. Packaging:... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Mens 50+ Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Mens Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Liposomal Womens 50+ Liquid Multivitamin Drops. Dosage: 3ml Liquid. Packaging:... recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - FulviLife Complex. Dosage:2 tablespoons recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. - Joint Nourish. Dosage:2 tablespoons recall (Wellnov Supplements LLC)
FoodClass IIReported May 27, 2026 · Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen contamination and possible C. Botulinum concerns. - MG217 Multi-Symptom Treatment Cream & Skin Protectant recall (Wisconsin Pharmacal Company)
DrugClass IReported May 27, 2026 · Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. - fentaNYL Citrate recall (IntegraDose Compounding Services LLC)
DrugClass IIReported May 27, 2026 · Subpotent Drug - cimzia recall (UCB Biosciences Inc.)
DrugClass IIReported May 27, 2026 · Lack of Assurance of Sterility - Erythromycin Tablets recall (Zydus Pharmaceuticals (USA) Inc)
DrugClass IIReported May 27, 2026 · CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit - Erythromycin Tablets recall (Zydus Pharmaceuticals (USA) Inc)
DrugClass IIReported May 27, 2026 · CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit - Estradiol Gel recall (ANI Pharmaceuticals, Inc.)
DrugClass IIReported May 27, 2026 · Defective Container; packets were found to be either empty or partially full. - Gas-X recall (Haleon US Holdings LLC)
DrugClass IIReported May 27, 2026 · Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. - Liraglutide Injection recall (Lupin Pharmaceuticals Inc.)
DrugClass IIReported May 27, 2026 · Presence of particulate matter: a white thread-like structure in the cartridge - Busulfan Injection recall (Sagent Pharmaceuticals)
DrugClass IIIReported May 27, 2026 · Failed Impurities/Degradation Specifications - Primidone Tablets recall (Amerisource Health Services LLC)
DrugClass IIIReported May 27, 2026 · Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Primidone Tablets recall (Amerisource Health Services LLC)
DrugClass IIIReported May 27, 2026 · Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Primidone Tablets recall (Golden State Medical Supply Inc.)
DrugClass IIIReported May 27, 2026 · Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Primidone Tablets recall (Golden State Medical Supply Inc.)
DrugClass IIIReported May 27, 2026 · Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Primidone Tablets USP recall (Lannett Company Inc.)
DrugClass IIIReported May 27, 2026 · Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Integris-Allura system recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported May 27, 2026 · The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in... - Allura system recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported May 27, 2026 · The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in... - Azurion system recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported May 27, 2026 · The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in... - Philips Azurion systems not configured with an optional auxiliary pan handle. Includes... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported May 27, 2026 · Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float... - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported May 27, 2026 · Certain lots of product have the potential for a sterile barrier breach. - Tangent Endoscopy recall (TANGENT ENDOSCOPY, LLC)
Medical deviceClass IIReported May 27, 2026 · Affected devices exhibited fractures at the distal shaft tip without complete detachment. - Bethlehem Lights Recalls Bethlehem Lights 10-inch Illuminated Ribbon Spheres Due to Risk of Serious Injury or Death from Fire Hazard; Sold by QVC
Consumer productReported May 26, 2026 · The LED lights on the recalled illuminated spheres can overheat, posing a risk of serious injury or death from a fire hazard. - ABC Trading Recalls WSDZ Light-up Glasses Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries
Consumer productReported May 26, 2026 · The recalled glasses violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries can be accessed... - PandaEar Recalls Portable Hook-On Chairs Due to Risk of Serious Injury or Death from Fall Hazard; Violates Mandatory Standard for Portable Hook-On Chairs
Consumer productReported May 26, 2026 · The recalled portable hook-on chairs violate the mandatory standard for portable hook-on chairs because the crotch restraints can be removed without the use of... - Lil Pick Up Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash and Burn Hazards; Violates Mandatory Standard for ATVs
Consumer productReported May 26, 2026 · The recalled youth ATVs violate the federal mandatory ATV safety standard, posing a risk of serious injury or death. The youth ATVs fail to meet mechanical... - Orb Funkee Squeeze Toys Recalled Due to Risk of Serious Injury or Death from Asbestos Exposure; Imported by The Orb Factory
Consumer productReported May 26, 2026 · The recalled Orb Funkee squeeze toys may contain fibrous tremolite (asbestos) in the sand, which can cause adverse health issues if inhaled. - Resistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym
Consumer productReported May 26, 2026 · The recalled resistance bands can forcefully separate from the handle during use, posing a risk of serious injury from impact hazard. - ABC Trading Recalls Children's Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys
Consumer productReported May 26, 2026 · The recalled children's toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that hold the batteries... - Dakota Honey Company the Honey Flight. 4 Flavors of Spreadable Spun Honey Original -... recall (Dakota Honey Company)
FoodClass IIReported May 20, 2026 · Foreign object (stainless steel dust/flakes or shreds of plastic) - Dakota Honey Company Spreadable Spun Honey recall (Dakota Honey Company)
FoodClass IIReported May 20, 2026 · Foreign object (stainless steel dust/flakes or shreds of plastic) - Dakota Honey Company Spreadable Spun Honey recall (Dakota Honey Company)
FoodClass IIReported May 20, 2026 · Foreign object (stainless steel dust/flakes or shreds of plastic) - Dakota Honey Company Spreadable Spun Honey recall (Dakota Honey Company)
FoodClass IIReported May 20, 2026 · Foreign object (stainless steel dust/flakes or shreds of plastic) - Dakota Honey Company Spreadable Spun Honey recall (Dakota Honey Company)
FoodClass IIReported May 20, 2026 · Foreign object (stainless steel dust/flakes or shreds of plastic) - Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID:... recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported May 20, 2026 · Out-of-specification endotoxin result that did not meet the acceptance criteria. - Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO recall (Edwards Lifesciences, LLC)
Medical deviceClass IIReported May 20, 2026 · Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.