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High RiskFDA
Xodus Medical Inc
Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
Surgical Devices·255,000 affected·Sep 19, 2019
High RiskFDA
Baxter Healthcare Corporation
TherMax Blood Warmer Unit
Medical Devices·504 affected·Sep 19, 2019
High RiskFDA
Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Medical Devices·678 affected·Sep 19, 2019
High RiskFDA
Xodus Medical Inc
Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
Surgical Devices·460,000 affected·Sep 19, 2019
High RiskFDA
Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Medical Devices·295 affected·Sep 19, 2019
High RiskFDA
Ra Medical Systems, Inc.
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser ...
Surgical Devices·5,082 affected·Sep 19, 2019
High RiskFDA
Pacific Medical Group Inc.
Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
Medical Devices·261 affected·Sep 19, 2019
High RiskFDA
Wismettac Asian Foods, Inc
Shirakiku Buckwheat Noodles Yamaimo Soba With Concentration Soup Base, 435G SK, UPC 074410455200 Distributed by Wismettac Asian Food...
Food·7,789 affected·Sep 18, 2019
High RiskFDA
Gcp Laboratories Inc
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N L...
Oral Drugs·31,392 affected·Sep 18, 2019
High RiskFDA
Avella Of Deer Valley, Inc. Store 38
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ ...
Ophthalmic Drugs·808 affected·Sep 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous sy...
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 50...
Medical Devices·11,389,800 affected·Sep 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous syst...
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Boston Scientific Corporation
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Medical Devices·150 affected·Sep 18, 2019
High RiskFDA
Gn Hearing A/s
In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-D...
Medical Devices·285 affected·Sep 18, 2019
High RiskFDA
Medline Industries Inc
EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case.
Diabetes Devices·761 affected·Sep 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous sys...
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Whole Flower Farms Llc
Fudge Brownie Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. ...
Dairy·7 affected·Sep 17, 2019
High RiskFDA
Whole Flower Farms Llc
Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. ...
Dairy·27 affected·Sep 17, 2019
High RiskFDA
Whole Flower Farms Llc
Peanut Butter Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted a...
Dairy·20 affected·Sep 17, 2019
High RiskFDA
Southeastern Grocers - Marketi
SE Grocers **BAKERY** 18 CT Peanut Butter Cookies
Dairy·125,439 affected·Sep 17, 2019
High RiskFDA
Akorn, Inc.
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
Drugs·10,543 affected·Sep 17, 2019
High RiskFDA
Cook Inc.
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for...
Medical Devices·41 affected·Sep 17, 2019
High RiskFDA
Axis-shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis...
Diagnostic Devices·740 affected·Sep 16, 2019
High RiskFDA
Axis-shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis ...
Diagnostic Devices·740 affected·Sep 16, 2019
High RiskFDA
Icecure Medical Ltd
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extre...
Surgical Devices·16 affected·Sep 16, 2019
High RiskFDA
Becton Dickinson & Company
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Cat...
Surgical Devices·75 affected·Sep 16, 2019
High RiskFDA
Infinite Herbs, Llc
Conventional Basil with Basil Infinite Herbs & Specialties brand label. Basil was packed in 2.5 oz plastic clamshell, 4.0 oz. plastic cla...
Food·2 affected·Sep 13, 2019
High RiskFDA
Mowi Usa, Llc
MOWI brand. Whole, head-on gutted farmed, fresh Atlantic Salmon packed with ice inside Styrofoam coolers. Each cooler weighs approximatel...
Seafood·2,492 affected·Sep 13, 2019
High RiskFDA
Abbott Laboratories
Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
Baby Food & Formula·2,922 affected·Sep 13, 2019
High RiskFDA
Guerbet Llc
Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power In...
Injectable Drugs·3,860 affected·Sep 13, 2019
High RiskFDA
Fortune International, Llc Dba Fortune Fish & Gourmet Llc
Fortune Fish & Gourmet fresh Atlantic salmon, whole, filleted, and filleted without belly sold by weight in cardboard box with ice
Seafood·2,004 affected·Sep 12, 2019
High RiskFDA
Star Fisheries, Inc.
Irish Salmon Organic Atl HON; 55 lb. cases received. Fresh Irish Salmon Fillet Ireland Farmed. Random weight boxes fillets cut and dis...
Seafood·310 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boc...
Drugs·10,630 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park ...
Drugs·3,410 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial),...
Drugs·95 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, ...
Drugs·120 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Supplements·6,325 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL),...
Topical Drugs·242 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Co...
Drugs·6,447 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blv...
Drugs·7,685 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 P...
Drugs·602 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL...
Drugs·345 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, ...
Injectable Drugs·0 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only...
Injectable Drugs·825 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Com...
Injectable Drugs·528 affected·Sep 12, 2019
High RiskFDA
Krs Global Biotechnology, Inc
Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park ...
Drugs·150 affected·Sep 12, 2019