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High RiskFDA
Puget Consumers Co-op
Hungarian Mushroom Soup sold at PCC Community Market as: (1) Sold in grab and go plastic retail container, net wt. 24 oz. UPC 2045220000...
Meat & Poultry·105 affected·Sep 30, 2024
High RiskFDA
Yucatan Products Dba Lorena Sandoval
El Gallo Azul Cock Brand Queso Procesado/Processed Cheese 300g packaged in a metal can
Dairy·15 affected·Sep 30, 2024
High RiskFDA
Nuvasive Specialized Orthopedics, Inc.
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Fe...
Medical Devices·164 affected·Sep 30, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Diagnostic Devices·7,332 affected·Sep 30, 2024
High RiskFDA
Bard Peripheral Vascular Inc
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; ...
Medical Devices·71,498 affected·Sep 30, 2024
High RiskFDA
Westby Cooperative Creamery
Westby Cheese Curds, UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Cooperative Creamery, West...
Dairy·914 affected·Sep 29, 2024
High RiskFDA
Westby Cooperative Creamery
Westby Pepper Cheese Curds, 12 oz. (340g) UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Coop...
Dairy·914 affected·Sep 29, 2024
High RiskFDA
Pacific Coast Fresh Co
King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusivel...
Produce·994 affected·Sep 28, 2024
High RiskFDA
Lund Food Holdings Inc
Lunds & Byerlys lone star dip. Net Wt 12 oz. (340.5g) UPC 0 18169-74197 9. Produced by Lunds & Byerlys, Edina, MN 55424.
Produce·756 affected·Sep 27, 2024
High RiskFDA
Accriva Diagnostics, Inc.
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Medical Devices·1 affected·Sep 27, 2024
High RiskFDA
Horizon Organic Dairy, Llc
Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per ca...
Dairy·2,956 affected·Sep 26, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model...
Medical Devices·0 affected·Sep 26, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Num...
Medical Devices·21,939 affected·Sep 26, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/...
Medical Devices·36,727 affected·Sep 26, 2024
High RiskFDA
King Systems Corp. Dba Ambu, Inc.
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Cat...
Medical Devices·21,591 affected·Sep 26, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton,...
Injectable Drugs·733 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·2,756 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-...
Injectable Drugs·753 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506...
Injectable Drugs·4,436 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton,...
Injectable Drugs·2,151 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·1,631 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71...
Injectable Drugs·1,008 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71...
Injectable Drugs·1,082 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·1,313 affected·Sep 25, 2024
High RiskFDA
Fresenius Kabi Compounding, Llc
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC...
Injectable Drugs·1,378 affected·Sep 25, 2024
High RiskFDA
Ethicon, Inc.
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Medical Devices·31,032 affected·Sep 25, 2024
High RiskFDA
Tropical Nut & Fruit Company
Grabeez The Big Cheese SNACK MIX Net Wt. 3.25 oz (92g) Ingredients: Peanuts***Cheese Pretzel Gems***Vegetable Shortening***Snackin' Mix**...
Dairy·173 affected·Sep 24, 2024
High RiskFDA
Nivagen Pharmaceuticals Inc
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA...
Oral Drugs·2,328 affected·Sep 24, 2024
High RiskFDA
Viona Pharmaceuticals Inc
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceutical...
Topical Drugs·2,544 affected·Sep 24, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net f...
Inhaled / Nasal Drugs·45,504 affected·Sep 24, 2024
High RiskFDA
Orthofix Srl
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Medical Devices·2 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex Arterial Kit 1/EA, Product Code REF MX7827
Medical Devices·2,232 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Medical Devices·0 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Medical Devices·10 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
Medical Devices·380 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Medical Devices·400 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Medical Devices·1,000 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Medical Devices·3,280 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Medical Devices·250 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Medical Devices·1,740 affected·Sep 24, 2024
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Medical Devices·1,292 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
Medical Devices·1,640 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Medical Devices·3,490 affected·Sep 24, 2024
High RiskFDA
Smiths Medical Asd, Inc.
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Medical Devices·1,110 affected·Sep 24, 2024
High RiskFDA
Medtronic Neuromodulation
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Medical Implants·39 affected·Sep 24, 2024
High RiskFDA
Salt City Baking Company, Llc
Sour Charlie bread, #2092, bag of 6 rolls (net wt. 7oz), 48 mini loaves per case. UPC code 0076011611894. Product was packaged bulk in...
Bakery & Grains·12 affected·Sep 23, 2024
High RiskFDA
Advanced Accelerator Applications Usa, Inc.
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Ac...
Injectable Drugs·99 affected·Sep 23, 2024
High RiskFDA
Pro-dex Inc
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgi...
Surgical Devices·2,000 affected·Sep 23, 2024