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High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Diagnostica Stago, Inc.
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and...
Diagnostic Devices·939 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson & Co.
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinam...
Medical Devices·12,256 affected·May 20, 2025
High RiskFDA
Onkos Surgical, Inc.
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplast...
Medical Devices·1 affected·May 20, 2025
High RiskFDA
Limacorporate S.p.a
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Medical Devices·9 affected·May 19, 2025
High RiskFDA
Element 112, Llc
1) Madeline's Patisserie 2.5 ounce Chocolate Croissant, Net Wt. 3 lbs. 8 oz. (1,587.6g), packaged in a food safe polypropylene bag and pa...
Snacks & Candy·1 affected·May 16, 2025
High RiskFDA
Element 112, Llc
Madeline's Patisserie 4.25 Inch Butter Croissant Bun, Net Wt. 4 lbs. 6 oz (1,984.47 g), packaged in a food safe polypropylene bag and pac...
Dairy·276 affected·May 16, 2025
High RiskFDA
Drs Vascular, Inc
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vasc...
Medical Devices·264 affected·May 16, 2025
High RiskFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Diagnostic Devices·34 affected·May 16, 2025
High RiskFDA
Therakos Development Limited
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Appl...
Medical Devices·5,826 affected·May 16, 2025
High RiskFDA
Amerisource Health Services Llc
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Heal...
Oral Drugs·21 affected·May 15, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim...
Oral Drugs·8,520 affected·May 15, 2025
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Ste...
Drugs·385,200 affected·May 15, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Medical Devices·174 affected·May 15, 2025
High RiskFDA
Contamac Solutions, Inc.
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Medical Devices·17,273 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
interventional fluoroscopic x-ray system
Medical Devices·0 affected·May 15, 2025
High RiskFDA
Asttrazeneca Pharmaceuticals Lp
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-90...
Drugs·807,837 affected·May 14, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Vallarai Rice Mix, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Traditional Sambar Powder, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Garlic Vadam, 100g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Tomato Vadam, 100g
Produce·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Traditional Rasam Powder, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Honey Heaven Wholesale Inc
Kraft package is labeled as Hummingbird Organic Roasted Salted Cashews, net wt. 6oz.
Food·210 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
NatureMills Curry Leaf Rice Mix, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Horsegram Soup, 100g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
NatureMills Avarampoo Soup, 100g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
NatureMills Moringa Rice Mix, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Wonderberry Leaf Soup, 100g
Produce·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Black Kavuni Porridge Mix, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
NatureMills Dal Garlic Rice Mix, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Sesame Rice Mix, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Horsegram Rice Mix, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Naturemills Us Incorporated
Nature Mills Rice Papad, 200g
Food·6,712 affected·May 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·22,152 affected·May 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zyd...
Oral Drugs·30,674 affected·May 13, 2025
High RiskFDA
Avkare
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Oral Drugs·3,817 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Medical Devices·28 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Medical Devices·37 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Medical Devices·9 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Medical Devices·72 affected·May 13, 2025
High RiskFDA
Spectral Instruments Inc
Ami HTX.
Medical Devices·34 affected·May 13, 2025