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High RiskFDA
Kobayashi Noodle U.s.a.
Product is distributed in 10lb bulk packaging. Brown cardboard box with generic label. Raw Ramen Noodle HA #22W (16049) UPC: NONE Manufac...
Food·945 affected·Aug 5, 2025
High RiskFDA
Khee Trading, Inc.
Product is Frozen Half Shell Oysters in 15 pound blacks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER ...
Seafood·828 affected·Aug 5, 2025
High RiskFDA
Kobayashi Noodle U.s.a.
Product is distributed in 10lb bulk packaging. Brown cardboard box with generic label. Raw Ramen Noodle HA #22W (4942) UPC: NONE Manufact...
Food·2,800 affected·Aug 5, 2025
High RiskFDA
Khee Trading, Inc.
Product is Frozen Half Shell Oysters in 15 pound blacks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER ...
Seafood·98 affected·Aug 5, 2025
High RiskFDA
Cardinal Health Inc.
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, R...
Injectable Drugs·10 affected·Aug 5, 2025
High RiskFDA
Sun Pharmaceutical Industries Inc
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124...
Oral Drugs·11,328 affected·Aug 5, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Medical Devices·458 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active L...
Medical Devices·15,441 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·25,778 affected·Aug 5, 2025
High RiskFDA
Tandem Diabetes Care, Inc.
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide whe...
Diabetes Devices·122,958 affected·Aug 5, 2025
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18...
Medical Devices·810 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural ...
Medical Devices·111,492 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·330 affected·Aug 5, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Descriptio...
Medical Devices·994 affected·Aug 5, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number...
Surgical Devices·6 affected·Aug 5, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5....
Medical Devices·1,369 affected·Aug 5, 2025
High RiskFDA
Hans Kissle Company, Llc
Hans Kissle Red Bliss Potato Salad
Produce·66 affected·Aug 4, 2025
High RiskFDA
B Braun Medical Inc
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medic...
Injectable Drugs·23,100 affected·Aug 4, 2025
High RiskFDA
B Braun Medical Inc
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical ...
Injectable Drugs·74,088 affected·Aug 4, 2025
High RiskFDA
Pfizer Inc
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409...
Injectable Drugs·49,620 affected·Aug 4, 2025
High RiskFDA
Pfizer Inc
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-...
Injectable Drugs·15,750 affected·Aug 4, 2025
High RiskFDA
Wasatch Photonics
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER...
Medical Devices·192 affected·Aug 4, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Medical Devices·57 affected·Aug 4, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i C...
Medical Devices·116 affected·Aug 4, 2025
High RiskFDA
Sri Sri Tattva
Sri Sri Tattva, Ojasvita Chocomalt,7oz / 200g, Paper Pouch, 25 packages per case
Food·1,100 affected·Aug 1, 2025
High RiskFDA
Dfa Dairy Brands, Llc
Carton Label: "Friendly's Vanilla Bean"; 48 fl. oz. Lid Label: "Friendly's Cookies and Cream" Product in carton is Cookies and Cream.
Dairy·54 affected·Aug 1, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numb...
Medical Devices·1,861 affected·Aug 1, 2025
High RiskFDA
Buffalo Rock Company Inc
7up Zero Sugar Tropical Soda, 12 FL OZ (355 mL) aluminum cans, packaged in 12 pack cardboard cartons labeled as 7up Tropical Flavored Sod...
Beverages·1,954 affected·Jul 31, 2025
High RiskFDA
Jayone Foods, Inc.
Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name: JBR KR-15-SP; Harvest Date: Feb 06, 2025 Shucked Date: Feb 07,2025 Expirati...
Meat & Poultry·180 affected·Jul 31, 2025
High RiskFDA
Jayone Foods, Inc.
Frozen Oyster Meat (IQF), Cert No. KR-15-SP; Processor Name: JBR KR-15-SP; Harvest Date: Feb 06, 2025 Shucked Date: Feb 07,2025 Expirati...
Meat & Poultry·225 affected·Jul 31, 2025
High RiskFDA
Lumicell, Inc.
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Mod...
Medical Devices·200 affected·Jul 31, 2025
High RiskFDA
Genogenix Llc
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Injectable Drugs·32 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·221 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·430 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Injectable Drugs·161 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·85 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, ...
Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·30 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·45 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·296 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·184 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Injectable Drugs·235 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. A...
Injectable Drugs·0 affected·Jul 30, 2025
High RiskFDA
Genogenix Llc
Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Injectable Drugs·294 affected·Jul 30, 2025