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High RiskFDA
Goodsource Solutions, Incorporated
Sauce, Creamy Butter; packaged in clear, unlabeled bulk 6-pound bags/4 bags to a case. Lot code# 701493 stamped on bag.
Dairy·1 affected·Apr 8, 2025
High RiskFDA
Inari Medical - Oak Canyon
Artix MT Thrombectomy Device, REF: 32-102
Medical Devices·45 affected·Apr 8, 2025
High RiskFDA
Beckman Coulter Inc.
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69...
Medical Devices·1,805 affected·Apr 8, 2025
High RiskFDA
Philips North America Llc
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm L...
Medical Devices·486,631 affected·Apr 7, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Medical Devices·996 affected·Apr 7, 2025
High RiskFDA
Science & Bio Materials
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Medical Devices·30 affected·Apr 7, 2025
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Medical Devices·4,174 affected·Apr 7, 2025
CriticalFDA
Trophy Nut Company
Heinen's Honey Roasted Peanuts, NET WT 8.25 OZ (234g), packaged in a composite can with plastic lid, 12 cans per case, Best If Used By: 1...
Food·143 affected·Apr 5, 2025
CriticalFDA
Supplement Manufacturing Partner Inc.
Spermidine, Maximum Strength, 10 mg per serving, Support healthy Aging, Dietary Supplement, 120 Capsules, oral consumption, shelf life: 2...
Supplements·6,465 affected·Apr 4, 2025
High RiskFDA
The Hot Chocolatier - St. Elmo, Llc
Blueberry Lemon Scones, bulk packaged in bakery boxes. Products are sold at retail in pastry cases and not individually labeled.
Bakery & Grains·25 affected·Apr 4, 2025
High RiskFDA
All American Trading Of Houston, Inc.
Texas Olive Co. Pepperoncini 16 oz glass jars
Food·207 affected·Apr 4, 2025
High RiskFDA
All American Trading Of Houston, Inc.
Texas Olive Company Capers Capote 8 oz. plastic containers. All lots with expiry prior to 06/04/2025 Texas Olive Company Capers Capote ...
Food·3,124 affected·Apr 4, 2025
High RiskFDA
Request Foods Incorporated
Cuban-Style Black Bean Soup, 4 / 4lb pouches, Net Wt. 16lb
Food·7,864 affected·Apr 4, 2025
High RiskFDA
Request Foods Incorporated
Moroccan Style Lentil Soup, 4 x 8lb pouches, Net wt. 32lb
Food·2,094 affected·Apr 4, 2025
High RiskFDA
Vaughan Mills Packaging Ltd.
Giant, Instant Oatmeal Raisins and Spice, 10 -1.5 oz. Packets, per box. Net. Wt. 15.01 oz.
Food·1,350 affected·Apr 4, 2025
CriticalFDA
Duda Farm Fresh Foods, Inc.
Marketside brand celery stick. Net wt. 1.6 OZ. (45g); Rear panel: 1 serving per container; Distributed by Wal-Mart Stores, Inc. Bentonvil...
Food·1,587 affected·Apr 4, 2025
High RiskFDA
Request Foods Incorporated
Mexican Street Corn Soup, 4 / 4lb pouches, Net Wt. 16lb
Food·7,388 affected·Apr 4, 2025
High RiskFDA
All American Trading Of Houston, Inc.
Texas Olive Company Giardiniera 16 oz. glass jars All lots with expiry prior to 06/14/2025
Food·811 affected·Apr 4, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Surgical Devices·6 affected·Apr 4, 2025
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PL...
Surgical Devices·189 affected·Apr 4, 2025
High RiskFDA
Klinika Mdical Gmb
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical devic...
Surgical Devices·160 affected·Apr 4, 2025
High RiskFDA
Supherb Farms
Label: FROZEN CHOPPED CILANTRO; PACK SIZE: 4 - 8 oz; NET WT: 2 lb; PERISHABLE - KEEP FROZEN; Packaging: 4 - 8 oz ziploc plastic bags in ...
Frozen Food·572 affected·Apr 3, 2025
High RiskFDA
Valley Fine Foods Co., Inc
CHILE VERDE EGG BITES; NET WT. 4.6 OZ (130 g); 2 egg bites/package
Food·646 affected·Apr 3, 2025
High RiskFDA
Gordon Desserts Dba Mochidoki
Sundae Shoppe, Cookies and Cream Mochi Ice Cream, 6 count, 7.5 oz, Plastic sealed tray inside paper carton. 6 Pieces per carton, 8 carto...
Dairy·5,016 affected·Apr 3, 2025
High RiskFDA
Supherb Farms
Label: IQF CILANTRO LARGE; NET WT: 30LB; PERISHABLE KEEP FROZEN; Packaging: blue plastic liner inside brown cardboard box
Frozen Food·96,000 affected·Apr 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Di...
Oral Drugs·3,144 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. ...
Medical Devices·908 affected·Apr 3, 2025
High RiskFDA
Wandercraft Sas
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabili...
Medical Devices·3 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 -...
Medical Devices·1,771 affected·Apr 3, 2025
High RiskFDA
Medtronic Neuromodulation
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medical Devices·534 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2...
Medical Devices·1,180 affected·Apr 3, 2025
CriticalFDA
Caraluzzi's Markets
Caraluzzi's Italian Style Seafood Burgers, 8oz; INGREDIENTS: Cod, Salmon, Shrimp, Scallops, Onions, Olive Oil, White Wine, Parsley, Sodiu...
Dairy·79 affected·Apr 2, 2025
High RiskFDA
Amerisource Health Services Llc
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, ...
Injectable Drugs·14,189 affected·Apr 2, 2025
High RiskFDA
Amerisource Health Services Llc
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 B...
Injectable Drugs·143 affected·Apr 2, 2025
High RiskFDA
Amerisource Health Services Llc
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhiha...
Injectable Drugs·2,110 affected·Apr 2, 2025
High RiskFDA
Getinge Disinfection Ab
Washer Disinfector Aquadis 56; Model Number: 56M
Medical Devices·424 affected·Apr 2, 2025
High RiskFDA
Getinge Disinfection Ab
Washer Disinfector Aquadis 56; Model Number: 56A
Medical Devices·102 affected·Apr 2, 2025
High RiskFDA
Panaderia Salvadorena Ii
PANADERIA/BAKERY Salvadorena; Quesadilla de Queso; Ingredients: Rice, Wheat Flour, soy, eggs, sugar, butter, baking powder, salt, water, ...
Dairy·180 affected·Apr 1, 2025
High RiskFDA
Tony's Chocolonely Inc
Tony's Chocolonely Everything Bar
Food·12,668 affected·Apr 1, 2025
High RiskFDA
Tony's Chocolonely Inc
Tony's Chocolonely Dark Chocolate Almond Sea Salt
Snacks & Candy·12,668 affected·Apr 1, 2025
High RiskFDA
Dr. Praeger's Sensible Foods Inc.
Dr. Praeger s California Veggie Fries 8oz,
Food·8,665 affected·Apr 1, 2025
High RiskFDA
Iba Dosimetry Gmbh
myQA iON; Article Number: MQ10-000;
Medical Devices·84 affected·Apr 1, 2025
High RiskFDA
Philips North America Llc
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Medical Devices·630 affected·Apr 1, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 8011...
Drugs·16,655 affected·Mar 31, 2025
High RiskFDA
Medisca Inc.
Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plat...
Drugs·161 affected·Mar 31, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters ...
Drugs·23,610 affected·Mar 31, 2025
High RiskFDA
B. Braun Medical Inc
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc.,...
Drugs·32,256 affected·Mar 31, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC...
Drugs·170 affected·Mar 31, 2025