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High RiskFDA
Karison Foods & Snacks, Inc.
Karison brand ALSI PINNI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Sugar Flax Seeds, Almonds, Zero Trans Fat, Vegetable Shorteni...
Dairy·230 affected·Jan 6, 2026
High RiskFDA
Encon Safety Products Co
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
Drugs·7,677 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·230,596 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·87,436 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·2,724 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·137,576 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·13,760 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·93,576 affected·Jan 6, 2026
High RiskFDA
Vantive Us Healthcare Llc
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical Devices·264,040 affected·Jan 6, 2026
RecallFDA
Straumann Usa Llc
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Medical Devices·561 affected·Jan 6, 2026
High RiskFDA
Biomerieux Inc
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev...
Medical Devices·2,668,954 affected·Jan 5, 2026
High RiskFDA
Raz Design Inc
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotationa...
Medical Devices·66 affected·Jan 5, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medical Devices·8,773 affected·Jan 5, 2026
High RiskFDA
Medline Industries, Lp
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOU...
Medical Devices·104,608 affected·Jan 5, 2026
High RiskFDA
Encore Medical, Lp
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Medical Devices·19 affected·Jan 5, 2026
High RiskFDA
Cipla Usa, Inc.
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA...
Injectable Drugs·15,221 affected·Jan 2, 2026
High RiskFDA
Avid Medical, Inc.
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Medical Devices·1,500 affected·Jan 2, 2026
High RiskFDA
Alphatec Spine, Inc.
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 Th...
Surgical Devices·15 affected·Jan 2, 2026
CriticalFDA
Wfm Purchasing, Lp
Brussel Sprouts & Kale Slaw
Food·88 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-II...
Ophthalmic Drugs·184,320 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, ...
Ophthalmic Drugs·50,400 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl...
Ophthalmic Drugs·5,760 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phas...
Topical Drugs·17,280 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt...
Ophthalmic Drugs·139,104 affected·Dec 31, 2025
High RiskFDA
Alvogen, Inc
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Di...
Oral Drugs·0 affected·Dec 31, 2025
High RiskFDA
Avkare
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: ...
Oral Drugs·7,991 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa P...
Ophthalmic Drugs·11,520 affected·Dec 31, 2025
High RiskFDA
Wizcure Pharmaa Private Limited
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. ...
Ophthalmic Drugs·10,080 affected·Dec 31, 2025
High RiskFDA
Medline Industries, Lp
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ...
Medical Devices·926,227 affected·Dec 31, 2025
High RiskFDA
Miach Orthopaedics
BEAR Implant. Model Number: 1000.
Medical Implants·284 affected·Dec 31, 2025
High RiskFDA
Medica Corporation
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Medical Devices·1,578 affected·Dec 31, 2025
High RiskFDA
Mondelez Global Llc
CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
Snacks & Candy·437 affected·Dec 30, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: G...
Oral Drugs·96,948 affected·Dec 30, 2025
RecallFDA
Sun Pharmaceutical Industries Inc
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10...
Topical Drugs·24,624 affected·Dec 30, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus...
Oral Drugs·22,896 affected·Dec 30, 2025
High RiskFDA
Intuitive Surgical, Inc.
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Medical Devices·47 affected·Dec 30, 2025
CriticalFDA
Whill, Inc.
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-whee...
Medical Devices·4,685 affected·Dec 29, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Medical Devices·41 affected·Dec 29, 2025
High RiskFDA
Cerapedics, Inc.
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Medical Devices·237 affected·Dec 29, 2025
CriticalFDA
Whill, Inc.
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel dri...
Medical Devices·2,324 affected·Dec 29, 2025
High RiskFDA
Central Admixture Pharmacy Services, Inc (caps) Los Angeles
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, ...
Injectable Drugs·1 affected·Dec 27, 2025
High RiskFDA
Gold Star Distribution Inc
All human food products distributed from the firm. Including but not limited to: snack foods, candy, gum, cooking oil, canned fruit and...
Dairy·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
LIQUID DAYQUIL 12/8oz
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
EXCEDRIN MIGRAINE 2'S- 25 CT
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Swan, White Clear Alcohol, 50%, 16oz, 12 count
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
Drugs·0 affected·Dec 26, 2025
High RiskFDA
Gold Star Distribution Inc
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: ...
Topical Drugs·0 affected·Dec 26, 2025