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High RiskFDA
M & P Food Productions, Ltd.
M&P Food Products Cheese & Cherry Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, l...
Dairy·0 affected·Aug 26, 2024
High RiskFDA
M & P Food Productions, Ltd.
Potato & Mushroom Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean...
Beverages·0 affected·Aug 26, 2024
High RiskFDA
Nova Ortho-med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MO...
Medical Devices·1,585 affected·Aug 26, 2024
High RiskFDA
Qualigen Inc
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Diagnostic Devices·60 affected·Aug 26, 2024
High RiskFDA
Nova Ortho-med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER M...
Medical Devices·1,886 affected·Aug 26, 2024
RecallFDA
Rubicon Research Private Limited
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by R...
Oral Drugs·3,984 affected·Aug 24, 2024
High RiskFDA
Flagstone Foods Llc
Wegmans PECAN BLEND NET WT 16OZ (1LB) 453g Ingredients: Pecans, Cashews, Pistachios, Canola and/or Peanut and/or Cottonseed Oil, Salt. Di...
Food·707 affected·Aug 23, 2024
High RiskFDA
La Fontanella Food Products Llc
54th St Blackened Sauce, 9lb bags - 4 bags per case.
Food·150 affected·Aug 23, 2024
High RiskFDA
Wingderm Electro-optics Ltd.
Non-ablative Fractional Laser Systems, Model: WFB-01
Medical Devices·0 affected·Aug 23, 2024
High RiskFDA
Young Dental Manufacturing I, Llc
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Medical Devices·1,391 affected·Aug 23, 2024
High RiskFDA
Wingderm Electro-optics Ltd.
Diode Laser Hair Removal model: WLA-01
Medical Devices·0 affected·Aug 23, 2024
High RiskFDA
Princeton Biomeditech Corp
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the ...
Diagnostic Devices·1,860 affected·Aug 23, 2024
High RiskFDA
Stryker Spine
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedur...
Medical Devices·8,589 affected·Aug 23, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Medical Devices·445 affected·Aug 23, 2024
High RiskFDA
American Outdoor Products, Inc.
American Outdoor Products - Astronaut Strawberries, packaged in 0.5oz (14g) metallic plastic pouches. Sold individually or in 6, 12, 40, ...
Produce·14,235 affected·Aug 22, 2024
High RiskFDA
Sri Lakshmi Narasimhar Overseas
Bliss Tree Millet Butter Karasev 200g UPC:8906087451686. Packaged in a box, 13 boxes per case.
Dairy·144 affected·Aug 22, 2024
High RiskFDA
Skagit River Bakery & Cafe
Marionberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bu...
Bakery & Grains·1,200 affected·Aug 22, 2024
High RiskFDA
Sri Lakshmi Narasimhar Overseas
Bliss Tree Moringa Butter Murukku 400g UPC:8906087452836. Packaged in pouches, 8 pouches per case.
Dairy·58 affected·Aug 22, 2024
CriticalFDA
Sri Lakshmi Narasimhar Overseas
Bliss Tree Millet Butter Murukku 200g UPC:8906087451631. Packaged in box, 13 boxes per cases. Bliss Tree Millet Butter Murukku 400g UPC:8...
Dairy·213 affected·Aug 22, 2024
High RiskFDA
Sri Lakshmi Narasimhar Overseas
Bliss Tree Millet Butter Ribbon Pakoda 200g UPC:8906087451624. Packaged in a box, 13 boxes per case. Bliss Tree Millet Butter Ribbon Pako...
Dairy·250 affected·Aug 22, 2024
High RiskFDA
Skagit River Bakery & Cafe
Blueberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bulk...
Bakery & Grains·1,200 affected·Aug 22, 2024
High RiskFDA
Sri Lakshmi Narasimhar Overseas
Bliss Tree Curry Leaves Butter Murukku 400g UPC:8906087452867. Packaged in pouches, 8 pouches per case.
Dairy·50 affected·Aug 22, 2024
High RiskFDA
Sri Lakshmi Narasimhar Overseas
Bliss Tree Ragi Butter Murukku 200g UPC:8906087451754. Packaged in a box, 13 boxes per case Bliss Tree Ragi Butter Murukku 400g UPC:89060...
Dairy·251 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
Injectable Drugs·37 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
Drugs·2,490 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
Injectable Drugs·500 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
Drugs·8,396 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Drugs·1,732 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Drugs·1,489 affected·Aug 22, 2024
High RiskFDA
Prorx Llc
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Drugs·1,960 affected·Aug 22, 2024
High RiskFDA
Medtronic Navigation, Inc.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is in...
Surgical Devices·1,801 affected·Aug 22, 2024
High RiskFDA
Healgen Scientific Llc
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing...
Diabetes Devices·1,636,994 affected·Aug 22, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion...
Medical Devices·7,091 affected·Aug 22, 2024
CriticalFDA
Kinova Inc
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the functi...
Medical Devices·949 affected·Aug 22, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722...
Medical Devices·250 affected·Aug 22, 2024
RecallFDA
My Chai Inc
Oregon Orchards Banana Smoothie Mix. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. I...
Beverages·2,355 affected·Aug 21, 2024
RecallFDA
My Chai Inc
MySyrup Sugar Free Salted Caramel Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz...
Beverages·459 affected·Aug 21, 2024
RecallFDA
My Chai Inc
MySyrup Sugar Free Caramel Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingr...
Beverages·604 affected·Aug 21, 2024
RecallFDA
My Chai Inc
MySyrup Sugar Free Madagascar Vanilla Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 f...
Beverages·3,171 affected·Aug 21, 2024
RecallFDA
My Chai Inc
MyChai Chai Tea Concentrate Super. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 68 fl oz. ...
Dairy·3,782 affected·Aug 21, 2024
CriticalFDA
Unilever North America Supply Chain Company, Llc
Popsicle Jolly Rancher Frozen Confection Pop Net Wt 2.71 FL OZ (80 ML). Green Apple Blue Raspberry and Grape flavored. GTIN/UPC 100775670...
Produce·146,000 affected·Aug 21, 2024
High RiskFDA
Orwaiian Llc
BDAY CAKE MOCHI CRUNCH packed in pink plastic pouch packaging, net wt. 5oz, UPC 7189147148, Orwaiian LLC, 465 NE Burnside Rd Gresham, OR ...
Dairy·720 affected·Aug 21, 2024
High RiskFDA
Inner Waymark Llc
Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt. 16oz (454g). Packaged in Kraft paper heat sealed stand-up ...
Snacks & Candy·60 affected·Aug 21, 2024
High RiskFDA
My Chai Inc
MyChai Chai Tea Concentrate Original. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is induction seal...
Dairy·19,061 affected·Aug 21, 2024
RecallFDA
My Chai Inc
MyChai Chai Tea Concentrate Original Double. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 6...
Dairy·19,171 affected·Aug 21, 2024
RecallFDA
My Chai Inc
MySyrup Sugar Free Peppermint Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. I...
Beverages·142 affected·Aug 21, 2024
RecallFDA
My Chai Inc
MySyrup Sugar Free Almond Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingre...
Beverages·212 affected·Aug 21, 2024
High RiskFDA
My Chai Inc
MyChai Chai Tea Concentrate KALI, 68 fl. oz. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is inducti...
Dairy·4,545 affected·Aug 21, 2024