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High RiskFDA
Eugia Us Llc
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia ...
Injectable Drugs·10,080 affected·Feb 20, 2024
RecallFDA
Contract Pharmaceuticals Limited Canada
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, O...
Topical Drugs·11,750 affected·Feb 20, 2024
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewoo...
Drugs·40,890 affected·Feb 20, 2024
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 137...
Injectable Drugs·40,090 affected·Feb 20, 2024
High RiskFDA
Boston Scientific Corporation
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult ...
Medical Devices·13 affected·Feb 20, 2024
RecallFDA
O&m Halyard, Inc.
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Surgical Devices·250 affected·Feb 20, 2024
CriticalFDA
Boston Scientific Corporation
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Medical Devices·985 affected·Feb 20, 2024
High RiskFDA
Boston Scientific Corporation
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult...
Medical Devices·572 affected·Feb 20, 2024
High RiskFDA
Boston Scientific Corporation
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult p...
Medical Devices·2,726 affected·Feb 20, 2024
High RiskFDA
Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 6638...
Medical Devices·20,533 affected·Feb 20, 2024
High RiskFDA
Seatex Llc
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
Drugs·274 affected·Feb 19, 2024
High RiskFDA
Seatex Llc
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445...
Topical Drugs·480 affected·Feb 19, 2024
High RiskFDA
Seatex Llc
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisc...
Topical Drugs·1,282 affected·Feb 19, 2024
High RiskFDA
Seatex Llc
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL c...
Drugs·1,450 affected·Feb 19, 2024
High RiskFDA
Seatex Llc
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magn...
Drugs·3 affected·Feb 19, 2024
CriticalFDA
Thoratec Corp.
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemptio...
Medical Implants·22,663 affected·Feb 19, 2024
CriticalFDA
Thoratec Corp.
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LV...
Medical Implants·2,240 affected·Feb 19, 2024
High RiskFDA
Convatec, Inc
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645,...
Medical Devices·6,709 affected·Feb 19, 2024
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640...
Surgical Devices·0 affected·Feb 17, 2024
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number:...
Surgical Devices·3,361 affected·Feb 17, 2024
High RiskFDA
Chin Jung Corporation
Chin Jung White Kimchi - 3 lb. 8 oz (1.58 kg) plastic jars
Food·1,274 affected·Feb 16, 2024
CriticalFDA
Raw Farm Llc
Raw Cheddar Cheese, made from unpasteurized milk, 8 oz (1/2 lb) block, Keep Refrigerated under 40 degrees
Dairy·0 affected·Feb 16, 2024
RecallFDA
Pressery, Llc
The label reads, "Golden Sunrise Cold Pressured Juice Carrot, Orange, Pineapple, Lemon, Ginger & Turmeric 11 fl. oz."
Beverages·57 affected·Feb 16, 2024
CriticalFDA
Raw Farm Llc
Raw Cheddar Cheese, made from unpasteurized milk, 16 oz (1 lb) block, Keep Refrigerated under 40 degrees
Dairy·0 affected·Feb 16, 2024
High RiskFDA
Chin Jung Corporation
Chin Jung White Kimchi - 7 lb. 8 oz.(3.4 kg) plastic jars
Food·680 affected·Feb 16, 2024
CriticalFDA
Raw Farm Llc
Raw Cheddar Cheese, made from unpasteurized milk, 8 oz (1/2 lb), shredded, in a plastic bag, Keep Refrigerated under 40 degrees
Dairy·0 affected·Feb 16, 2024
High RiskFDA
Global Corporation
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic ...
Drugs·9,831 affected·Feb 16, 2024
High RiskFDA
Global Corporation
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in...
Drugs·2,345 affected·Feb 16, 2024
High RiskFDA
Medivance Inc.
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Medical Devices·1,654 affected·Feb 16, 2024
High RiskFDA
Biosense Webster, Inc.
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide acces...
Cardiac Devices·853 affected·Feb 16, 2024
High RiskFDA
Coopersurgical, Inc.
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Medical Devices·770 affected·Feb 16, 2024
High RiskFDA
Medtronic Inc.
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Medical Implants·65 affected·Feb 16, 2024
RecallFDA
Nicomex Inc.
Nicomex Tequesquite, Net Wt. 1.5oz (42.52gms), UPC: 8 8467810180 7. Packaged in a plastic bag.
Food·192 affected·Feb 15, 2024
High RiskFDA
Turkana Food Inc.
Sekeroglu Lokum Love Turkish Delight Mixed With Pistachio And Pomegranate Flavor Wrap Delight 350 grams UPC:8683454050627. Packaged in a ...
Food·72 affected·Feb 15, 2024
High RiskFDA
Turkana Food Inc.
Sekeroglu Lokum Love Turkish Delight With Pistachio And Pomegranate Flavor Double Roasted Delight 350 grams UPC:8683454050542. Packaged i...
Food·72 affected·Feb 15, 2024
CriticalFDA
Eugia Us Llc
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugi...
Injectable Drugs·1,552 affected·Feb 15, 2024
High RiskFDA
Bio-rad Laboratories
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Medical Devices·33 affected·Feb 15, 2024
High RiskFDA
Masimo Corporation
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Medical Devices·21,723 affected·Feb 15, 2024
High RiskFDA
Masimo Corporation
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Medical Devices·65 affected·Feb 15, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1...
Medical Implants·1,579 affected·Feb 15, 2024
High RiskFDA
Masimo Corporation
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Medical Devices·443 affected·Feb 15, 2024
High RiskFDA
Masimo Corporation
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Medical Devices·4,978 affected·Feb 15, 2024
High RiskFDA
Philips North America Llc
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips...
Medical Devices·555 affected·Feb 15, 2024
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Matt...
Surgical Devices·7 affected·Feb 15, 2024
High RiskFDA
Capitol Commissary Llc
Jacksons Egg Salad, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983642540991.
Produce·1,195 affected·Feb 14, 2024
High RiskFDA
Capitol Commissary Llc
CK Egg Salad Sandwich, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983644000097.
Produce·52 affected·Feb 14, 2024
RecallFDA
Synergy Flavors Inc
NAT & ART HAZELNUT TYPE FLAVOR #521510, in 6 gallon and "275" tote
Food·11,940 affected·Feb 14, 2024
CriticalFDA
Capitol Commissary Llc
Jacksons Turkey and Cheese Sandwich, net wt. 6.7oz. Product is closed-face sandwich and ready to eat product. UPC 983642601562. The san...
Dairy·1,382 affected·Feb 14, 2024