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High RiskFDA
Suntree Snack Foods, Llc
Lightly Salted Cashews Halves & Pieces, 40 oz. , UPC 842379195358. 6 bags/case.
Food·120 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
Roasted Lightly Salted Cashew Halves and Pieces, 8 oz. , UPC 072036734884. 8 bags/case.
Food·1,715 affected·Sep 24, 2021
High RiskFDA
Suntree Snack Foods, Llc
100 Calorie Packs Lightly Salted Roasted Cashews Halves & Pieces, 12.4 oz. , 20 packs/bag, UPC 041220178339. 4 master bags/case.
Food·7,664 affected·Sep 24, 2021
High RiskFDA
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 7...
Medical Devices·428 affected·Sep 24, 2021
High RiskFDA
Monarch Pcm, Llc
Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, T...
Topical Drugs·11,419 affected·Sep 23, 2021
High RiskFDA
Implant Direct Sybron Manufacturing Llc
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Medical Implants·83 affected·Sep 23, 2021
High RiskFDA
Diasorin Molecular Llc
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Medical Devices·1,690 affected·Sep 23, 2021
High RiskFDA
Implant Direct Sybron Manufacturing Llc
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Medical Implants·61 affected·Sep 23, 2021
High RiskFDA
Kelly's Bakery Corp.
Brownie Chocolate Walnuts, Carton with 96 retail units, A210107B
Snacks & Candy·4 affected·Sep 22, 2021
High RiskFDA
New Vitalis Pharmacy Llc Dba New Vitalis Pharmacy
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louis...
Drugs·1,347 affected·Sep 22, 2021
High RiskFDA
Teva Pharmaceuticals Usa
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC F...
Drugs·1,978 affected·Sep 22, 2021
High RiskFDA
Teva Pharmaceuticals Usa
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by:...
Drugs·3,240 affected·Sep 22, 2021
High RiskFDA
Teva Pharmaceuticals Usa
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LL...
Drugs·4,850 affected·Sep 22, 2021
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. ...
Drugs·385 affected·Sep 22, 2021
High RiskFDA
Teva Pharmaceuticals Usa
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC...
Drugs·5,500 affected·Sep 22, 2021
High RiskFDA
Teva Pharmaceuticals Usa
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: ...
Drugs·10,665 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS RUB IgG (RBG), REF 30226
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS FSH, REF 30407-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Diagnostic Devices·261 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS SARS-COV-2 IgM, Ref 423833-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS Estradiol II, REF 30431-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS Lyme IgG II (LYM), REF 417401
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS PRG Progesterone, REF 30409-01
Medical Devices·1,818 affected·Sep 22, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Diagnostic Devices·149 affected·Sep 22, 2021
High RiskFDA
Biomerieux, Inc.
VIDAS LH, REF 30406-01
Medical Devices·0 affected·Sep 22, 2021
High RiskFDA
Sigmapharm Laboratories Llc
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case ...
Drugs·1,192 affected·Sep 21, 2021
High RiskFDA
Sanitor Corporation
Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave...
Drugs·0 affected·Sep 21, 2021
High RiskFDA
Olympus Corporation Of The Americas
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port a...
Medical Devices·350 affected·Sep 21, 2021
High RiskFDA
Intuitive Surgical, Inc.
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Ca...
Surgical Devices·1,740 affected·Sep 21, 2021
High RiskFDA
Philips Ultrasound Inc
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Diagnostic Devices·107 affected·Sep 21, 2021
High RiskFDA
Smith & Nephew, Inc.
6.5MMX165MM CANNULATED SCREW
Medical Devices·5 affected·Sep 20, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Medical Devices·246 affected·Sep 20, 2021
High RiskFDA
Farmers' All Natural Creamery Llc
Kalona Supernatural Organic Half & Half, Manufactured in Iowa for Kalona Organics, LLC. Kalona IA in 16 FL OZ (UPC 8-81245-12516-7, 8 bot...
Food·114 affected·Sep 17, 2021
High RiskFDA
Farmers' All Natural Creamery Llc
Kalona Supernatural Organic Whole Chocolate Milk, Manufactured in Iowa for Kalona Organics, LLC. Kalona IA in 16 FL OZ (UPC 8-81245-10516...
Dairy·123 affected·Sep 17, 2021
High RiskFDA
Farmers' All Natural Creamery Llc
Kalona Supernatural Organic Whipping Cream, Manufactured in Iowa for Kalona Organics, LLC. Kalona IA in 16 FL OZ (UPC 8-81245-12016-2, 8 ...
Dairy·253 affected·Sep 17, 2021
High RiskFDA
Integradose Compounding Services Llc
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Min...
Injectable Drugs·2,614 affected·Sep 17, 2021
High RiskFDA
American Health Packaging
GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured...
Oral Drugs·2,266 affected·Sep 17, 2021
High RiskFDA
Fresenius Kabi Usa Llc
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 2...
Injectable Drugs·963,000 affected·Sep 17, 2021
High RiskFDA
Integradose Compounding Services Llc
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave S...
Injectable Drugs·589 affected·Sep 17, 2021
High RiskFDA
Bio-rad Laboratories, Inc.
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is inten...
Diagnostic Devices·791 affected·Sep 17, 2021
High RiskFDA
Elekta, Inc.
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c...
Medical Devices·4,405 affected·Sep 17, 2021
High RiskFDA
Bio-rad Laboratories, Inc.
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow...
Diagnostic Devices·11,610 affected·Sep 17, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Chocolate Cherry ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·8 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Mocha! ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·18 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, S'mores! ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·7,915 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Luscious Lemon ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·36 affected·Sep 15, 2021
High RiskFDA
Picket Fence Creamery L.l.c.
Picket Fence Creamery, Woodward, IA, Maple ice cream, in Quarts, Pints, and 1/2 Pints
Dairy·18 affected·Sep 15, 2021