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High RiskFDA
Biofire Diagnostics, Llc
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Medical Devices·29 affected·Feb 27, 2025
High RiskFDA
Premier Dental Products Co
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Medical Devices·77 affected·Feb 27, 2025
RecallFDA
Paletas Ice Cream, Llc
Flor de Michoacan Blue Hawaiian Artificially Flavored Beverage Concentrate. 1 Gallon (3.78L) Pasteurized. Keep Frozen. UPC 1 80596-00...
Dairy·23 affected·Feb 26, 2025
High RiskFDA
Intuitive Surgical, Inc.
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . ...
Medical Devices·439 affected·Feb 26, 2025
CriticalFDA
Covidien
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Medical Devices·780 affected·Feb 26, 2025
High RiskFDA
A-s Medication Solutions Llc
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-149...
Oral Drugs·411 affected·Feb 25, 2025
High RiskFDA
Mylan Pharmaceuticals Inc
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 03...
Oral Drugs·0 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and ...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Medical Devices·93 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Medical Devices·40 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional a...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500, Product Code 4091000
Medical Devices·1,709 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Stationary column TruSystem 7500, Product Code 1717020
Medical Devices·462 affected·Feb 25, 2025
High RiskFDA
Philips North America Llc
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and...
Surgical Devices·0 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Medical Devices·2 affected·Feb 25, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Medical Devices·8 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
Medical Devices·182,344 affected·Feb 25, 2025
High RiskFDA
Stryker Corporation
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Medical Devices·0 affected·Feb 25, 2025
RecallFDA
Kowa Pharmaceuticals America
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Compa...
Oral Drugs·5,328 affected·Feb 24, 2025
High RiskFDA
Denison Pharmaceuticals, Llc
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 80...
Topical Drugs·642,131 affected·Feb 24, 2025
RecallFDA
Imprimis Njof, Llc
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Impri...
Ophthalmic Drugs·2,822 affected·Feb 24, 2025
High RiskFDA
Pyrames Inc
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Medical Devices·35 affected·Feb 24, 2025
High RiskFDA
Prep'd Cda Llc
Chocolate Peanut Butter Protein Balls. Product has expected life of 2 weeks and does not require refrigeration. Product is packaged in se...
Dairy·240 affected·Feb 23, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Shake No Sugar Added (4 oz), UPC 10045796017372; Imperial Strawberry Shake No Sugar Added (4 oz), UPC 00074865926843
Produce·763,250 affected·Feb 21, 2025
High RiskFDA
Shearer's Foods, Llc
1.) Market Pantry Soup & Oyster Crackers, NET WT 9 OZ (255g), packaged in flexible plastic bags, 12 count per case, Distributed By: Targe...
Seafood·1 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Shake (4 oz), UPC 10045796017358; Imperial Strawberry Shake (4 oz), UPC 00074865927017
Produce·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Shake Plus (4 oz), UPC 10045796017495
Produce·763,250 affected·Feb 21, 2025
High RiskFDA
Danone Wave
HAZELNUT INTERNATIONAL delight COFFEE CREAMER 32 FL OZ (1 QT) 32 FL OZ (1 QT) 946 mL UPC 0 41271 02565 2 Distributed by: Danone US, LLC
Beverages·4,762 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Chocolate Shake No Sugar Added (4 oz), UPC 10045796036335; Imperial Chocolate Shake No Sugar Added (4 oz), UPC 10734730244720
Snacks & Candy·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Vanilla Shake No Sugar Added (4 oz), UPC 10045796017365; Imperial Vanilla Shake No Sugar Added (4 oz), UPC 00074865927031
Food·763,250 affected·Feb 21, 2025
High RiskFDA
Danone Wave
CINNABON CLASSIC CINNAMON ROLL INTERNATIONAL delight COFFEE CREAMER 32 FL OZ (1 QT) 946 mL UPC 0 41271 01993 3 Distributed by: Danone US,...
Beverages·7,747 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Vanilla Shake (4 oz), UPC 10045796017334; Imperial Vanilla Shake (4 oz), UPC 00074865926836
Food·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Chocolate Shake (4 oz), UPC 10045796017341; Imperial Chocolate Shake (4 oz), UPC 00074865926997
Snacks & Candy·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Chocolate Shake Plus (4 oz), UPC 10045796017471
Snacks & Candy·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Strawberry Banana Shake No Sugar Added (4 oz), UPC 10045796018447; Imperial Strawberry Banana Shake No Sugar Added (4 oz), UP...
Produce·763,250 affected·Feb 21, 2025
CriticalFDA
Lyons Magnus Llc
Ready Care Vanilla Shake Plus (4 oz), UPC 10045796017549
Food·763,250 affected·Feb 21, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Medical Devices·468 affected·Feb 21, 2025
CriticalFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 S...
Drugs·1,546 affected·Feb 20, 2025