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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
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
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
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
High RiskFDA
Chin Jung Corporation
Chin Jung White Kimchi - 7 lb. 8 oz.(3.4 kg) plastic jars
Food·680 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
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
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
High RiskFDA
Capitol Commissary Llc
Jacksons Chicken Salad On A Croissant, net wt. 6.7oz. Product is closed-face sandwich on a croissant and ready to eat product. UPC 98364...
Meat & Poultry·1,179 affected·Feb 14, 2024
High RiskFDA
Golden State Medical Supply Inc.
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toron...
Inhaled / Nasal Drugs·59,712 affected·Feb 14, 2024
High RiskFDA
Covidien, Lp
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Medical Devices·30 affected·Feb 14, 2024
High RiskFDA
Covidien, Lp
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Medical Devices·3,023 affected·Feb 14, 2024
High RiskFDA
Randox Laboratories Ltd.
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog N...
Diagnostic Devices·666 affected·Feb 14, 2024
High RiskFDA
Amy's Kitchen Inc.
Gluten Free Bean and Cheese Burrito (5.5 oz), individual plastic overwrap, 12 retail units/case, frozen
Dairy·5,567 affected·Feb 13, 2024
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridg...
Oral Drugs·46,037 affected·Feb 13, 2024
High RiskFDA
Cardona Foods, Inc.
Uncooked Tortillas: FTC010 - Flour Tortilla 6 Taco Casa- 18/20 Count 18/22oz 18/624 grams FTC030 - Flour Tortilla 10 Taco Casa- 10/12...
Food·9,302 affected·Feb 12, 2024
High RiskFDA
Mckesson Corporation
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use...
Oral Drugs·42 affected·Feb 12, 2024
High RiskFDA
Micro Labs Limited
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs US...
Oral Drugs·24,768 affected·Feb 12, 2024
High RiskFDA
Sarnova Hc, Llc
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number...
Medical Devices·550 affected·Feb 12, 2024
High RiskFDA
M-c Mclane International
Jalapenos packed in 6lb 10oz cans. 6 cans per case
Food·2,991 affected·Feb 10, 2024
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage ...
Oral Drugs·8,198 affected·Feb 9, 2024
High RiskFDA
Micro Labs Limited
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: ...
Oral Drugs·118,080 affected·Feb 9, 2024
High RiskFDA
Apotex Corp.
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontari...
Inhaled / Nasal Drugs·292,752 affected·Feb 9, 2024
High RiskFDA
Preat Corp
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Medical Devices·561 affected·Feb 9, 2024
High RiskFDA
Ptw-freiburg
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data set...
Medical Devices·1 affected·Feb 8, 2024
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Medical Devices·26,592 affected·Feb 8, 2024