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CriticalFDA
Akt Trading Inc.
Choshiya branded "MENMA AJITSUKE PREPARED BAMBOO SHOOTS" UPC# JANCODE 4983673527325
Food·3,600 affected·Feb 18, 2025
CriticalFDA
Akt Trading Inc.
Choshiya branded "FUKUSHIN ZUKE PREPARED MIX VEGETABLES" UPC# JANCODE 4582207535142
Produce·1,400 affected·Feb 18, 2025
CriticalFDA
Akt Trading Inc.
Choshiya branded "AOKAPPA ZUKE PREPARED MIX VEGETABLES" UPC# JANCODE 4582207535135
Produce·600 affected·Feb 18, 2025
CriticalFDA
Carefusion 303, Inc.
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Medical Devices·0 affected·Feb 18, 2025
CriticalFDA
Kenover Marketing Corp.
Glicks Dark Chocolate Conettos, 2.47 oz., Plastic Bag, 24 packages per case
Snacks & Candy·840 affected·Feb 17, 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
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
CriticalFDA
Smiths Medical Asd, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Medical Devices·175,994 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
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
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
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
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
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
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
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·1,695 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/...
Medical Devices·0 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Surgical Devices·643 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Surgical Devices·3 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF ...
Surgical Devices·2,236 affected·Feb 13, 2025
CriticalFDA
Smiths Medical Asd, Inc.
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Surgical Devices·2,311 affected·Feb 13, 2025
CriticalFDA
Je Bakery 2019 Llc
Raisin Bran muffins, 6 count. Net Wt. 12.0 oz (0.75 lb) UPC 0 29341-00233 7. Labeled with the following store brands: Cub Foods, Jerry...
Food·78 affected·Feb 12, 2025
CriticalFDA
Remel, Inc
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ...
Medical Devices·41 affected·Feb 12, 2025
CriticalFDA
Jack & The Green Sprouts, Inc.
Jack & the Green Sprouts Alfalfa Sprouts. Net Weight 5 oz. (152g). UPC 7 63247-19891 5. Keep Refrigerated. Product of USA. River Fa...
Food·2,688 affected·Feb 6, 2025
CriticalFDA
Medtronic Perfusion Systems
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA...
Medical Devices·316,205 affected·Feb 5, 2025
CriticalFDA
Bard Peripheral Vascular Inc
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 8...
Medical Devices·15,755 affected·Feb 5, 2025
CriticalFDA
Turkana Food Inc.
Aleppo Tahini Sesame Paste, 32oz, Plastic jar, 1lb (16oz), 12 per case
Food·858 affected·Jan 31, 2025
CriticalFDA
Nestle-usa, Inc. (corporate Office)
Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Banana NET WT 3.2 OZ (90g) box UPC 0 15000 04608 8 and NET WT 1.59 oz box UPC 0 15...
Snacks & Candy·34,652 affected·Jan 31, 2025
CriticalFDA
Nestle-usa, Inc. (corporate Office)
Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Strawberry Apple NET WT 3.2 OZ (90g) UPC 0 15000 04518 7 GERBER PRODUCTS CO., FREM...
Snacks & Candy·314,398 affected·Jan 31, 2025
CriticalFDA
Alvogen, Inc
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc....
Drugs·112,128 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Diabetes Devices·106,289 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Diabetes Devices·70,587 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Diabetes Devices·8,677 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
Paradigm REF: MMT-712 and MMT-715
Medical Devices·20,760 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 620G (MMT-1750)
Diabetes Devices·228 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
Paradigm insulin pump, REF: MMT-754
Diabetes Devices·41,404 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Diabetes Devices·168,240 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Diabetes Devices·46,437 affected·Jan 31, 2025
CriticalFDA
Micro Therapeutics, Inc.
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-2...
Medical Devices·7,820 affected·Jan 30, 2025
CriticalFDA
Micro Therapeutics, Inc.
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-3...
Medical Devices·18,245 affected·Jan 30, 2025
CriticalFDA
Freshpoint Central Florida, Inc.
Garden Salad 5 oz Lot # 6620223 Best By: 02.05, UPC 766375733300
Produce·18 affected·Jan 28, 2025
CriticalFDA
Ascent Consumer Products Inc.
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natur...
Inhaled / Nasal Drugs·4,176 affected·Jan 28, 2025
CriticalFDA
Ascent Consumer Products Inc.
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP...
Inhaled / Nasal Drugs·0 affected·Jan 28, 2025
CriticalFDA
Ascent Consumer Products Inc.
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All N...
Inhaled / Nasal Drugs·0 affected·Jan 28, 2025
CriticalFDA
New York Wholesale Group
ZAARAH HERBALS brand SHATAVARI POWDER; 100% ASPARAGUS RACEMOSUS; (Supports Female Reproductive System); Supreme Fine Powder 100g (3.5 oz)...
Food·1,584 affected·Jan 27, 2025
CriticalFDA
United Natural Trading Inc. Dba Woodstock Farms
Fresh Direct Dark Chocolate Pretzels 7oz, Bag. 12 bags per case.
Snacks & Candy·99 affected·Jan 27, 2025