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High RiskFDA
Prima Vera Nueva, Inc.
Mushroom, Spinach & Salsa Tamales No Dairy Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Tomatoes, Onions, Jalapenos, Non-hy...
Dairy·16,264 affected·Dec 12, 2025
High RiskFDA
House Of Flavors, Inc.
2248 Banana Pudding Ice Cream, 3 GAL, UPC 7 65265 81237 8
Dairy·34,561 affected·Dec 12, 2025
CriticalFDA
Medinatura New Mexico, Inc.
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquer...
Inhaled / Nasal Drugs·0 affected·Dec 12, 2025
High RiskFDA
Merck Sharp & Dohme Llc
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07...
Oral Drugs·3 affected·Dec 12, 2025
CriticalFDA
Medinatura New Mexico, Inc.
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4...
Inhaled / Nasal Drugs·0 affected·Dec 12, 2025
High RiskFDA
Merck Sharp & Dohme Llc
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Shar...
Oral Drugs·845 affected·Dec 12, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitori...
Medical Devices·1,301 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU ...
Medical Devices·117 affected·Dec 12, 2025
High RiskFDA
Elekta, Inc.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description...
Medical Devices·0 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medical Devices·0 affected·Dec 12, 2025
High RiskFDA
Bard Peripheral Vascular Inc
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Surgical Devices·14,935 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion system; Software Version Number: R3.1;
Medical Devices·228 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit ...
Medical Devices·1,928 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-L...
Medical Devices·456 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESI...
Medical Devices·1,928 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medical Devices·60 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) ...
Cardiac Devices·857 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ...
Medical Devices·96 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit...
Cardiac Devices·1,928 affected·Dec 12, 2025
High RiskFDA
Hologic, Inc
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Medical Devices·3,728 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DY...
Medical Devices·236 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, K...
Medical Devices·1,928 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: ...
Medical Devices·10,466 affected·Dec 12, 2025
High RiskFDA
Ukrop's Homestyle Foods, Llc
Ukrop's 6" Pound Cake with Buttercream Icing/Confetti NET WT 30 OZ (1.88lb/851g) CONTAINS: Egg, Milk, Wheat Made in a production area tha...
Dairy·61 affected·Dec 11, 2025
High RiskFDA
Ukrop's Homestyle Foods, Llc
Ukrop's 6" Pound Cake with Buttercream Icing/Pink Roses NET WT 44 OZ (2.75lb/1.25kg) CONTAINS: Egg, Milk, Wheat Made in a production area...
Dairy·61 affected·Dec 11, 2025
High RiskFDA
Ukrop's Homestyle Foods, Llc
Ukrop's 6" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8" Pound Cake with Butt...
Dairy·61 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lum...
Medical Implants·148 affected·Dec 11, 2025
High RiskFDA
Applied Medical Resources Corp
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Medical Devices·450 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description...
Medical Devices·117 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product De...
Diagnostic Devices·23 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lu...
Medical Implants·179 affected·Dec 11, 2025
CriticalFDA
White Castle System
White Castle Original Sliders, Net Wt. 6.35 oz. (180g), packaged as a 4-count carton, each containing 2-Two Packs. UPC 082988029693, pack...
Food·1,021 affected·Dec 10, 2025
High RiskFDA
The James Skinner Llc
Publix Raspberry Coffee Cake, Net Wt. 15 oz. (425g), packaged in an aluminum foil tray and clear plastic clamshell lid with wraparound la...
Bakery & Grains·811 affected·Dec 10, 2025
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Medical Devices·1 affected·Dec 10, 2025
CriticalFDA
Repligen Corporation
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Medical Devices·33 affected·Dec 10, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
SMV DSI, System, Tomography, Computed, Emission
Medical Devices·3 affected·Dec 10, 2025
High RiskFDA
Sun Pharma /taro
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY...
Drugs·17,664 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catal...
Surgical Devices·6,152 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Numbe...
Surgical Devices·7,819 affected·Dec 9, 2025
High RiskFDA
Heraeus Medical Gmbh (dental Division)
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A ...
Medical Devices·0 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Numbe...
Surgical Devices·2,660 affected·Dec 9, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Mo...
Surgical Devices·86,904 affected·Dec 9, 2025
High RiskFDA
Weaver's Brew Llc
Goldenroot Lemon Ginger Jalapeno Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32820 7. Keep Cold. Manufactured By Goldenroot, 3841 Market...
Food·421 affected·Dec 8, 2025
High RiskFDA
Weaver's Brew Llc
Goldenroot Yuzu Ginger Lemongrass Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32817 7. Keep Cold. Manufactured By Goldenroot, 3841 Marke...
Food·649 affected·Dec 8, 2025
High RiskFDA
Weaver's Brew Llc
Goldenroot Lemon Double Ginger, Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32819 1. Keep Cold. Manufactured By Goldenroot, 3841 Market ...
Food·1,070 affected·Dec 8, 2025
High RiskFDA
Weaver's Brew Llc
Goldenroot Lemon Ginger Elderberry Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32818 4. Keep Cold. Manufactured By Goldenroot, 3841 Mark...
Produce·1,066 affected·Dec 8, 2025
CriticalFDA
Sam Dry Fruits And Nuts Enterprises, Inc
Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027
Meat & Poultry·32,610 affected·Dec 8, 2025
High RiskFDA
Bakkavor
MEAL SIMPLE RED LENTIL DAL SOUP NET WT. 16 OZ (1 LB) 454g UPC 1 97870 07333 0 MADE WITH PRIDE AND CARE FOR H-E-B-, SAN ANTONIO, TEXAS 78204
Food·291 affected·Dec 8, 2025