RecallRadar

Shanghai Ravioli Corporation Recalls Not Ready-To-Eat Frozen Buffalo Chicken Products Produced Without the Benefit of Inspection

Produced Without Benefit of Inspection

CCM Hockey U.S. Recalls FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories Due to Risk of Injury from Laceration or Impact Hazards

The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact hazards.

Goal Zero Recalls YETI 3000X Power Stations Due to Serious Risk of Injury from Fire and Burn Hazards

The recalled power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.

JINHEZO Mini Waterproof LED Tea Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries; Imported by Mystic ZO

The LED Tea Lights violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

Koorlian Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability; Sold on Amazon by Dream Bedding Technology

Dreams Bedding Technology PTE. Ltd., of Singapore

The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.

KTM North America Recalls Off-Road Motorcycles Due to Risk of Serious Injury or Death from Crash Hazard

The rear brake caliper can crack or break, reducing the brake system's effectiveness, posing a risk of serious injury or death due to crash hazard.

Modine Manufacturing Company Recalls Airedale Heating and Cooling Ventilation Fans Due to Fire Hazard

Modine Manufacturing Company, of Racine, Wisconsin

The ventilation fan motor in the heat pumps can short circuit if water gets on the circuit board, causing the units to overheat and posing a fire hazard.

Workbless Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and Electrocution Hazards

Guangzhou Ao Lian Ya Wang Luo Ke Ji You Xian Gong Si, dba Workbless, of China

The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or death from shock and electrocution hazards.

Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Kroger, Medium, 30 Eggs, Net Wt 52.5 oz (3lb 4.5oz) 596g, UPC 0 11110-60980 9. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Kroger, Large 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-60903 8. Distributed by The Kroger Co., Cincinnati, OH 45202. 4. Kroger

MIDWEST POULTRY SERVC C/O H & LELECTRIC

Possible Salmonella Enteritidis

Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case.

Bazzini LLC

Undeclared peanuts

MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.

Taylor Farms de Mexico S. de R.L. de C.V.

Potential Cyclospora contamination.

Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730

FlavorsandColor.Com

Undeclared Red #40.

Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.

SHEANDRO LLC

Label declares cream and cheese, but Milk is not declared

Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-87032 0. Distributed by The Kroger Co., Cincinnati, OH 45202. 2. Simple Truth, Natural Cage Free Grain Fed, Large, 12 Eggs, Net Wt 24 oz (1lb 8oz) 681g, UPC 0 11110-79770 4. Distributed by The Kroger Co., Cincinnati, OH 45202. 3. Simple Truth, Natural Cage Free Grain Fed, Large, 18 Eggs, Net Wt 36 oz (2

MIDWEST POULTRY SERVC C/O H & LELECTRIC

Possible Salmonella Enteritidis

Kian Pee Wan Capsules, 30-count bottles

Buy-Herbal

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

Victory Medical Center Pharmacy

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.

Liebel-Flarsheim Company LLC

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

Heritage Pharmaceuticals Inc

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3

Prestige Brands Holdings

Lack of assurance of sterility. The recall is due to potential contamination

SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

Baxter Healthcare Corporation

Presence of Particulate Matter

SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34

Novartis Pharmaceuticals Corporation

Failed Dissolution Specifications

SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03

Apollo Care, LLC

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.

W L Gore & Associates, Inc.

10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).

Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog

Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884

Covidien, LP

Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.

BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems.

MICROVENTION INC.

Due to an increase rate of balloon pinhole defects.

Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY

Cardinal Health 200, LLC

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Firmware issue potentially leading to loss of geometry movements.

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Terumo Medical Corporation

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN

Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN

Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.

Spectra Medical Devices, Llc

Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Baxter Healthcare Corporation

Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.