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High RiskFDA
Alcon Research, Ltd.
Infinity FMS Pak
Medical Devices·51,054 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
Surgical Devices·775 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
Surgical Devices·299 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
Surgical Devices·299 affected·Jun 28, 2023
High RiskFDA
Maquet Cardiovascular, Llc
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Cardiac Devices·401 affected·Jun 28, 2023
High RiskFDA
Maquet Cardiovascular, Llc
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization sy...
Cardiac Devices·785 affected·Jun 28, 2023
High RiskFDA
Maquet Cardiovascular, Llc
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Cardiac Devices·334 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
Surgical Devices·519 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
Surgical Devices·600 affected·Jun 28, 2023
High RiskFDA
Alcon Research, Ltd.
Alcon Custom Pak
Medical Devices·1,682,351 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Surgical Devices·69,987 affected·Jun 28, 2023
CriticalFDA
Covidien Lp
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
Surgical Devices·6,615 affected·Jun 28, 2023
RecallFDA
Lupin Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21...
Oral Drugs·3,096 affected·Jun 27, 2023
CriticalFDA
Cipla Usa, Inc.
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured...
Drugs·278,538 affected·Jun 27, 2023
High RiskFDA
Zimmer, Inc.
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation an...
Medical Devices·75 affected·Jun 27, 2023
High RiskFDA
Pegasus Foods, Inc.
Cream Cheese Rangoon NET WT: 5.00 LB. (2.26 KG) CT/CS: 100 PS (5 TRAYS X 20 PCS UPC: (01)10664383187016(15)112823(10)0601233A1W package i...
Dairy·38,887 affected·Jun 26, 2023
CriticalFDA
Rose Street Bread Lab
Rose Street Patisserie Multi Grain Bread. Net Wt. 375 grams. 882 7th Street West, St. Paul, MN 55102
Bakery & Grains·27 affected·Jun 26, 2023
High RiskFDA
Strides Pharma Inc.
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limi...
Oral Drugs·2,700 affected·Jun 26, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-co...
Oral Drugs·541 affected·Jun 26, 2023
High RiskFDA
Digisonics, Inc
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Medical Devices·32 affected·Jun 26, 2023
High RiskFDA
Paragon Vision Sciences, Inc
ISee Ortho-K Lens
Medical Devices·83,542 affected·Jun 26, 2023
High RiskFDA
Paragon Vision Sciences, Inc
Fargo Ortho-K Lens
Medical Devices·18,820 affected·Jun 26, 2023
High RiskFDA
Cargill, Inc Corporate Headquarters
Cargill Tripotassium Citrate Monohydrate packaged in 50 lb. paper bag. Product item: SKU 100105392, TPC GNLR 50LB BG KH FCC
Food·10,000 affected·Jun 23, 2023
High RiskFDA
Cargill, Inc Corporate Headquarters
Cargill Trisodium Citrate Dihydrate packaged in 50 lb. paper bags and 2,000 lb. supersacks. Product item ids: 1. SKU 100002299, TSC DI...
Food·1,610,900 affected·Jun 23, 2023
CriticalFDA
Estancia Holdings
FABRIQUE' EN CORSE TOMME CORSE AU LAIT DE BREBIS***ANTOINE OTTAVI FROMAGER***aFFINAGE 3 A' 5 MOIS SARL Fromagerie Ottavi 20240 Ghisonacci...
Food·1 affected·Jun 23, 2023
CriticalFDA
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg...
Oral Drugs·4,179 affected·Jun 23, 2023
RecallFDA
Vivus, Inc.
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UP...
Oral Drugs·4,240 affected·Jun 23, 2023
High RiskFDA
Kramer Laboratories, Inc.
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), ...
Drugs·0 affected·Jun 23, 2023
High RiskFDA
Amerisource Health Services Llc
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: Am...
Oral Drugs·4,971 affected·Jun 23, 2023
High RiskFDA
Kramer Laboratories, Inc.
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc....
Drugs·0 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descri...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product D...
Surgical Devices·321,609 affected·Jun 23, 2023
High RiskFDA
Microtek Medical Inc.
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/cas...
Medical Devices·9,293 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Descrip...
Surgical Devices·321,609 affected·Jun 23, 2023
High RiskFDA
Scholly Fiberoptic Gmbh
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into...
Medical Devices·98 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Produc...
Surgical Devices·321,609 affected·Jun 23, 2023
CriticalFDA
Datascope Corp.
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descripti...
Surgical Devices·321,609 affected·Jun 23, 2023
High RiskFDA
Cytrellis Biosystems, Inc.
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles ...
Medical Devices·127 affected·Jun 23, 2023
CriticalFDA
Fma International Llc
Fromagerie Ottavi Tome Corse Sheep Milk Cheese
Dairy·1 affected·Jun 22, 2023
High RiskFDA
Jost Chemical Co
Zinc Sulfate Monohydrate, USP, Powder. Net Wt: 55 lb / 25 kg. Jost Chemical 8150 Lackland, St. Louis, MO 63114. Caution: For Manufac...
Food·9,680 affected·Jun 22, 2023
High RiskFDA
Alembic Pharmaceuticals, Inc.
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. ...
Topical Drugs·2,844 affected·Jun 22, 2023
High RiskFDA
Scican Ltd.
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by mea...
Medical Devices·19 affected·Jun 22, 2023
High RiskFDA
Wilson-cook Medical Inc.
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for e...
Medical Devices·402 affected·Jun 22, 2023
High RiskFDA
Creganna Medical Devices
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Medical Devices·194 affected·Jun 22, 2023
High RiskFDA
Wilson-cook Medical Inc.
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for ...
Medical Devices·393 affected·Jun 22, 2023
CriticalFDA
Santos Frozen Foods
Regular Deviled Crabs, 4oz
Seafood·520 affected·Jun 21, 2023
CriticalFDA
Santos Frozen Foods
Mini Deviled Crabs, 1oz
Seafood·100 affected·Jun 21, 2023
High RiskFDA
Garelick Farms Llc
Tampico brand Mango Punch; LESS THAN 1% JUICE; 1 GAL (3.78 L); INGREDIENTS: WATER, HIGH FRUCTOSE CORN SYRUP, LESS THAN 2% OF MANGO JUICE ...
Beverages·2,156 affected·Jun 21, 2023