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High RiskFDA
Fujifilm Healthcare Americas Corporation
Surpria 64: Software Version V3.11, V3.22
Medical Devices·16 affected·Jul 12, 2022
High RiskFDA
Fujifilm Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
Medical Devices·46 affected·Jul 12, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07...
Injectable Drugs·301,400 affected·Jul 11, 2022
High RiskFDA
Tolmar, Inc.
Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510...
Topical Drugs·1,271 affected·Jul 11, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Ca...
Injectable Drugs·713,550 affected·Jul 11, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Ca...
Injectable Drugs·82,700 affected·Jul 11, 2022
Medium RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, ND...
Topical Drugs·654,756 affected·Jul 11, 2022
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 06...
Injectable Drugs·4,739,000 affected·Jul 11, 2022
High RiskFDA
Wissner-bosserhoff Gmbh
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Medical Devices·77 affected·Jul 11, 2022
CriticalFDA
Intera Oncology, Inc.
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Medical Implants·50 affected·Jul 10, 2022
RecallFDA
The Procter & Gamble Company
Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual ca...
Drugs·1,128 affected·Jul 8, 2022
High RiskFDA
Oculus Optikgeraete Gmbh
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Medical Devices·92 affected·Jul 8, 2022
High RiskFDA
Refresco Beverages Us Inc
Clear American brand "Strawberry Punch Snow Cone" flavored sparkling water beverage with other natural flavors; 1-liter clear plastic bot...
Beverages·87 affected·Jul 7, 2022
High RiskFDA
Portland Specialty Baking Llc
Lemon Muffins, item # 802387, are packaged in paper tray and covered with plastic film shrink wrap. Each tray contains 6 pieces and ther...
Food·160 affected·Jul 7, 2022
High RiskFDA
Apotex Corp.
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 6050...
Oral Drugs·2,010 affected·Jul 7, 2022
High RiskFDA
Olympus Corporation Of The Americas
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Medical Devices·2 affected·Jul 7, 2022
High RiskFDA
Oxford Immunotec Ltd
T-Cell Xtend REF TTK.610 US
Medical Devices·47 affected·Jul 7, 2022
High RiskFDA
Boston Scientific Corporation
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse ge...
Medical Implants·17,172 affected·Jul 7, 2022
High RiskFDA
Oxford Immunotec Ltd
T-SPOT.TB REF TB.300 US
Medical Devices·81 affected·Jul 7, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 34033-12, Chuckanut Bay Chocolate Covered Coconut Cheesecake Bites. Perishable - Keep Refrigerated. There are 8 pieces per pack and...
Dairy·18 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 34021-12, Chuckanut Bay Cheesecake Bites Berry. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. ...
Dairy·34,021 affected·Jul 6, 2022
High RiskFDA
Bumble Bee Foods, Llc
Bumble Bee Smoked Clams Shucked Easy Open NET WT. 3.75 oz. (106 g) Distributed By: Bumble Bee Seafoods San Diego, CA 92186 USA Product ...
Seafood·9,756 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 35001-12, Chocolate Covered CHEESECAKE BITES NY SIGNATURE. Edible brand. Distributed by Wish Foods, LLC. Perishable - Keep Refrige...
Dairy·35,001 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 34032-12, Chuckanut Bay Cheesecake Bites Lemon. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per case. N...
Dairy·18 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 32017-56, Chocolate Cheesecake Bites BULK. Perishable - Keep Refrigerated. There are 14 pieces per pack and 56 packs per case. ...
Dairy·66 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 39421-12, Chuckanut Bay DIPPED CHEESECAKE BITES Berry. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs per...
Dairy·154 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 81109-12, Chuckanut Bay Sharis Strawberry Cheesecake Bites. Perishable - Keep Refrigerated. There are 9 pieces per pack and 12 pack...
Dairy·22 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 39417-12, Chuckanut Bay DIPPED CHEESECAKE BITES Chocolate. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs...
Dairy·154 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 32012-56, Chuckanut Bay Key Lime Cheesecake Bites (Dark Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pa...
Dairy·22 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 34017-12, Chuckanut Bay Cheesecake Bites Chocolate. Perishable - Keep Refrigerated. There are 8 pieces per pack and 12 packs per ca...
Dairy·34,017 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 39408-12, Chuckanut Bay DIPPED CHEESECAKE BITES Pumpkin. Perishable - Keep Refrigerated. There are 4 pieces per pack and 12 packs p...
Dairy·132 affected·Jul 6, 2022
High RiskFDA
Chuckanut Bay Foods Llc
Item 32001-56, Chuckanut Bay New York Cheesecake Bites (Milk Compound) BULK. Perishable - Keep Refrigerated. There are 14 pieces per pac...
Dairy·32,001 affected·Jul 6, 2022
CriticalFDA
Tovala
Tovala Gochujang-Glazed Salmon Bowl meal No.18-A
Seafood·12,562 affected·Jul 5, 2022
CriticalFDA
Tovala
Tovala Gochujang-Glazed Pork Chop Bowl meal No.9-A
Meat & Poultry·3,340 affected·Jul 5, 2022
CriticalFDA
Mylan Pharmaceuticals Inc
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of ...
Injectable Drugs·253,200 affected·Jul 5, 2022
High RiskFDA
Zap Surgical Systems
ZAP-X Radiosurgery System
Medical Devices·8 affected·Jul 5, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Oral Tip Syringe 0.5ml Code: OT005
Medical Devices·120 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
Medical Devices·9 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Oral Tip Syringe 2.5ml Code: OT25
Medical Devices·20 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
Medical Devices·1 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Reusable Oral syringe 5ml Code: OTH05
Medical Devices·26 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Oral Tip Syringe 1ml Code: OT01
Medical Devices·29 affected·Jul 4, 2022
High RiskFDA
Medicina Uk Ltd
Medicina Reusable Oral syringe 2.5ml Code: OTH25
Medical Devices·20 affected·Jul 4, 2022
High RiskFDA
Abbott Laboratories
Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8...
Food·179 affected·Jul 3, 2022
CriticalFDA
Arborypharm Foods Inc.
Natreve Vegan Protein Powder 10 servings, 13.1oz (371g), UPC 628831120003 18 servings, 1.47lbs/23.53oz (667g), UPC 628831110073
Food·6,683 affected·Jul 3, 2022
CriticalFDA
Big Olaf Creamery Llc Dba Big Olaf
Big Olaf, Frozen Ice Cream to include all flavors, sold in sizes 2.5 gal, 1/2 gal, and pints packaged in plastic containers.
Dairy·0 affected·Jul 1, 2022
High RiskFDA
Intuitive Surgical, Inc.
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, ...
Medical Devices·62,895 affected·Jul 1, 2022
High RiskFDA
Enjoy Life Natural Brands, Llc
Enjoy Life Chewy Bars Caramel Blondie (Chocolate Chip and Caramel), 5.75 oz (165g) UPC 819597011258 and 819597011333
Snacks & Candy·89,736 affected·Jun 30, 2022