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High RiskFDA
Daye (anne's Day Ltd)
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Se...
Medical Devices·11,850 affected·Feb 17, 2025
High RiskFDA
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT...
Medical Devices·62,877 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 ...
Medical Devices·350 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT...
Medical Devices·3,800 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Daye (anne's Day Ltd)
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Medical Devices·3,074 affected·Feb 17, 2025
High RiskFDA
Zb Importing Llc
Ulker Dankek Roll Cake Strawberry , item 8298, 8.3oz foil pack, 8 per case, UPC 8690504066828
Bakery & Grains·145 affected·Feb 15, 2025
High RiskFDA
Zb Importing Llc
Ulker Dankek Roll Cake Chocolate, item 9584, 3oz foil pack, 8 per case, UPC 8690504067979
Bakery & Grains·482 affected·Feb 15, 2025
High RiskFDA
Great Lakes Cheese Co Inc
Happy Farms by ALDI Colby Jack (a blend of Colby & Monterey Jack finely shredded cheeses), Net Wt. 12 OZ (340g), packaged in flexible pla...
Dairy·400 affected·Feb 15, 2025
High RiskFDA
Zb Importing Llc
Ulker Kekstra Mini strawberry, item 3792, 5.3oz foil pack, 10 per case, UPC 8690766082307
Produce·433 affected·Feb 15, 2025
High RiskFDA
Zb Importing Llc
Ulker Dankek Roll Cake Banana, item 9620, 8.3oz foil pack, 8 per case, UPC 8690504067986
Bakery & Grains·453 affected·Feb 15, 2025
CriticalFDA
Zb Importing Llc
Ulker Biskrem Cocoa Biscuit, item 8836, 10.6oz foil pack, 8 per case, UPC 8690504114628
Food·1,881 affected·Feb 15, 2025
CriticalFDA
Zb Importing Llc
Ulker Rulokat Hazelnut Wafers, item 3865, 6oz plastic cylinder, 6 per case, UPC 8690766086473
Food·2,289 affected·Feb 15, 2025
CriticalFDA
Mauna Loa Macadamia Nut Company, Llc
Mauna Loa Milk Chocolate Covered Macadamias product is a snack product and packaged in plastic 1oz pouch. Each carton contains 12 pouches...
Dairy·74 affected·Feb 14, 2025
High RiskFDA
The Karma Sauce Company Llc
HOT ONES brand ROJO, Los Calientes Hot Sauce, BY HEATONIST; 5 oz size and 1 gallon sizes; UPC: 8-51444-00810-03
Food·1 affected·Feb 14, 2025
High RiskFDA
The Karma Sauce Company Llc
HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5
Food·1 affected·Feb 14, 2025
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin ...
Drugs·205,440 affected·Feb 14, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Medical Devices·37 affected·Feb 14, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Medical Devices·175,994 affected·Feb 14, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Medical Devices·20 affected·Feb 14, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Medical Devices·175,994 affected·Feb 14, 2025
High RiskFDA
World Perfumes Inc.
Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distribut...
Drugs·3,900 affected·Feb 13, 2025
High RiskFDA
Johnson, S C And Son, Inc
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, D...
Inhaled / Nasal Drugs·493,462 affected·Feb 13, 2025
CriticalFDA
Icu Medical, Inc.
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, ...
Drugs·0 affected·Feb 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC...
Injectable Drugs·1,893 affected·Feb 13, 2025
CriticalFDA
Icu Medical, Inc.
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinoi...
Drugs·67,488 affected·Feb 13, 2025
High RiskFDA
Johnson, S C And Son, Inc
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277...
Inhaled / Nasal Drugs·449,502 affected·Feb 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC...
Injectable Drugs·36,978 affected·Feb 13, 2025
High RiskFDA
Remel, Inc
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Diagnostic Devices·316 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Description: The Powerhe...
Cardiac Devices·7,221 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,...
Surgical Devices·1,490 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Medical Implants·0 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C,...
Cardiac Devices·960 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introdu...
Surgical Devices·8,515 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Surgical Devices·1,118 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., ...
Surgical Devices·12 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Ve...
Cardiac Devices·73 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-...
Cardiac Devices·1,312 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., ...
Surgical Devices·1 affected·Feb 13, 2025
High RiskFDA
Zoll Medical Corporation
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A,...
Cardiac Devices·2,268 affected·Feb 13, 2025