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High RiskFDA
Ultra Seal Corporation
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Oral Drugs·447,050 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
Oral Drugs·25,776 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count...
Oral Drugs·147,528 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Drugs·1,019,000 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Oral Drugs·409,890 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
Oral Drugs·1,309,800 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) packaged in a) 40-count blisters and b) 20-count...
Oral Drugs·702,240 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47...
Oral Drugs·1,959,267 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carr...
Oral Drugs·447,190 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
Oral Drugs·297,050 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, In...
Oral Drugs·0 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
Drugs·1,694,200 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Oral Drugs·307,000 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactur...
Oral Drugs·11,401,641 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus...
Oral Drugs·122,400 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packet...
Oral Drugs·227,010 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI...
Oral Drugs·216,000 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Ad...
Oral Drugs·1,180,000 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) ...
Oral Drugs·313,000 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfiel...
Oral Drugs·448,300 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
Drugs·40,344 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coat...
Oral Drugs·225,000 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products U...
Oral Drugs·1,474,050 affected·Jan 24, 2022
High RiskFDA
Ultra Seal Corporation
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
Oral Drugs·1,351,660 affected·Jan 24, 2022
High RiskFDA
Argon Medical Devices, Inc
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Medical Devices·600 affected·Jan 24, 2022
High RiskFDA
Matrix Medical Network
Matrix Clinical Solution At-Home COVID-19 Test
Medical Devices·3,226 affected·Jan 24, 2022
High RiskFDA
Arillis Corp
Tortillas Arillis, Arillis Corp, Contains: 10 (ten) tortillas
Food·300 affected·Jan 21, 2022
High RiskFDA
Mylan Pharmaceuticals Inc
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed ...
Topical Drugs·233,199 affected·Jan 21, 2022
High RiskFDA
Integra Lifesciences Corp.
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and...
Medical Devices·1,160 affected·Jan 21, 2022
High RiskFDA
Nrt X-ray A/s
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C...
Medical Devices·72 affected·Jan 21, 2022
High RiskFDA
Neumodx Molecular Inc
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in in...
Diagnostic Devices·102 affected·Jan 21, 2022
High RiskFDA
Surgical Innovations Ltd
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Medical Devices·1 affected·Jan 20, 2022
High RiskFDA
Envisiontec Us Llc
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impac...
Medical Devices·172 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Medical Devices·11,970 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Medical Devices·3,240 affected·Jan 20, 2022
High RiskFDA
Sight Diagnostics Ltd
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image ...
Diagnostic Devices·322 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Medical Devices·49,760 affected·Jan 20, 2022
High RiskFDA
Surgical Innovations Ltd
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparosc...
Medical Devices·19 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
LUMBAR PUNCTURE DRUG FREE TRAY 22G
Medical Devices·2,880 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Medical Devices·8,630 affected·Jan 20, 2022
High RiskFDA
Bard Peripheral Vascular Inc
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Medical Devices·1,260 affected·Jan 20, 2022
High RiskFDA
Microgenics Corporation
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMU...
Diagnostic Devices·615 affected·Jan 20, 2022
High RiskFDA
Frozen Food Development Inc
Steamable by Lidl Chopped Spinach NET WT 12 OZ (340 g) UPC 4 056489 34380 6. Frozen product.
Produce·0 affected·Jan 19, 2022
High RiskFDA
Fetting's Frozen Foods Llc
Abbys Bakery Homestyle White Bread Dough. Product number 93596. Keep Frozen. 4-1 lb. loaves. Net Wt. 4 lbs. (1.81kg) UPC 40730-93596...
Bakery & Grains·83 affected·Jan 19, 2022
High RiskFDA
Amys Kitchen Inc
Amy's Vegan Organic Rice Mac & Cheese; frozen; 8 oz. (227 g) individually packaged serving; in trays with plastic overwrap, inside prepri...
Dairy·43 affected·Jan 19, 2022
High RiskFDA
Volcano Corporation
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Medical Devices·3,216 affected·Jan 19, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended fo...
Diagnostic Devices·2,846 affected·Jan 19, 2022
High RiskFDA
Walla Walla Cheese Company Llc
Walla Walla Cheese Company Mad Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags - net wt. 5 lbs. and 10 oz.
Dairy·48 affected·Jan 18, 2022