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High RiskFDA
Keurig Dr Pepper, Inc.
McCafe Premium Roast Decaf Coffee K-Cup Pods, Net Wt. 29 oz (823g), packaged as an 84-count carton, UPC 043000073438. Distributed By: Keu...
Beverages·960 affected·Dec 6, 2025
High RiskFDA
Bharat Bazar
SOMA KITCHEN NATURAL ASAFOETIDA Net Wt. 4 oz (0.25 lb) Product of India Manufactured for and Imported by: Bharat Bazar, Fremont, CA 94539...
Food·180 affected·Dec 5, 2025
High RiskFDA
Fresh & Ready Foods Llc
Spicy Breakfast Burrito, Sprig & Sprout brand, Ready to Eat. Refrigerated. Net wt. 9.1oz. UPC 100001000297, SS00297v02. Fresh & Ready Foo...
Food·93 affected·Dec 5, 2025
High RiskFDA
Fresh & Ready Foods Llc
Spicy Veggie Breakfast Burrito, Fresh to You, Ready to Eat, Refrigerated. Net wt. 9.1oz. UPC 100000010310, LPK110310V06. Fresh & Ready Fo...
Food·278 affected·Dec 5, 2025
High RiskFDA
Fresh & Ready Foods Llc
Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & R...
Dairy·62 affected·Dec 5, 2025
High RiskFDA
Fresh & Ready Foods Llc
Eggs Potatoes Cheese Tacos, Evergreen Refreshments brand, Ready to Eat, Refrigerated. Net wt. 6.3 oz. UPC 100040103898, EG03698v01. Fresh...
Dairy·200 affected·Dec 5, 2025
High RiskFDA
Beaver-visitec International, Inc.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Medical Devices·5 affected·Dec 5, 2025
High RiskFDA
Meridian Bioscience Inc
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Diagnostic Devices·211 affected·Dec 5, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Medical Devices·1 affected·Dec 5, 2025
High RiskFDA
Az Gems, Inc.
Jumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6
Seafood·1,099 affected·Dec 4, 2025
High RiskFDA
Lil Turtles Llc
Grandma Belle's Tomato Basil Soup, Net Wt. 17 oz. (482g), packaged in a glass jar, UPC 810084612293, Made By: Lil' Turtles 504 North Ray ...
Produce·110 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Allwell Inflation Device, for angiographic use REF: IS-30-A
Medical Devices·173,645 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4...
Medical Devices·4,163,123 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Manifold Kit REF: K09-13203A
Medical Devices·2,192 affected·Dec 4, 2025
High RiskFDA
Mobius Imaging, Llc
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Medical Devices·101 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Medical Devices·864 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A...
Medical Devices·18,897 affected·Dec 4, 2025
High RiskFDA
Mccain Foods Usa Inc
Sysco Imperial Potato Tater Barrel, item number 1000006067. Frozen potato product is packaged in 6/5 lb. clear unlabeled poly bags per ca...
Frozen Food·17,597 affected·Dec 3, 2025
High RiskFDA
Mccain Foods Usa Inc
Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt...
Frozen Food·21,256 affected·Dec 3, 2025
High RiskFDA
Philips North America
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Philips Healthcare (suzhou) Co., Ltd.
Philips Incisive CT
Medical Devices·35 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Carefusion 303, Inc.
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421...
Medical Devices·2,079 affected·Dec 3, 2025
High RiskFDA
Medtronic Neuromodulation
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and o...
Medical Devices·7,123 affected·Dec 3, 2025
High RiskFDA
Philips North America
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Medical Devices·3 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Medical Devices·24 affected·Dec 3, 2025
High RiskFDA
Philips North America
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Medical Devices·9 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Medical Devices·6 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Medical Devices·31 affected·Dec 3, 2025
High RiskFDA
Philips North America
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Philips North America
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Medical Devices·3 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Medical Devices·21 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Medical Devices·5 affected·Dec 3, 2025
High RiskFDA
Philips North America
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Medical Devices·6 affected·Dec 3, 2025
High RiskFDA
Lily's Bakery Factory
Cuban Crackers Galletas Cubanas, Net Wt 8Oz (226g). Distributed by Best Floridian, LLC. UPC 5700300060
Bakery & Grains·890 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Medical Devices·86 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Softwa...
Medical Devices·3 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Softwa...
Medical Devices·11 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Medical Devices·18 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Medical Devices·1 affected·Dec 2, 2025
High RiskFDA
Hangzhou Bever Medical Devices Co., Ltd.
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Surgical Devices·149,310 affected·Nov 29, 2025