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High RiskFDA
Cardinal Health 200, Llc
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Medical Devices·6,517 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Medical Devices·198 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Medical Devices·193 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia 1.5T S; Model Number: 781347;
Medical Devices·2 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Medical Devices·12 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Medical Devices·300 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Medical Devices·65 affected·May 13, 2025
High RiskFDA
Spectral Instruments Inc
Lago X
Medical Devices·39 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Medical Devices·16 affected·May 13, 2025
High RiskFDA
Cardinal Health 200, Llc
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort ...
Medical Devices·6,517 affected·May 13, 2025
High RiskFDA
Philips North America Llc
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Medical Devices·152 affected·May 13, 2025
High RiskFDA
Bd Switzerland Sarl
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Medical Devices·1,655,300 affected·May 12, 2025
High RiskFDA
Hemocue Ab
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that mult...
Diabetes Devices·4 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, R...
Medical Devices·1,265,400 affected·May 12, 2025
High RiskFDA
Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Medical Devices·8,027 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Medical Devices·1,006,512 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 1001...
Medical Devices·2,024,780 affected·May 12, 2025
High RiskFDA
Fresh & Ready Foods Llc
Fresh & Ready Foods Veggie Snack Bistro Box, 4 oz. plastic container. Best buy: 05/09/2025-05/12/2025 UPC# 6 82906 89912 6
Snacks & Candy·139,863 affected·May 10, 2025
High RiskFDA
Publix Super Markets, Inc.
Greenwise Pear Kiwi Spinach & Pea Baby Food Pouch. Net Wt 4 oz. (113g). Stage 2 6 months+, Best if" date of 11/01/2025. Packed in 14 pouc...
Produce·53,620 affected·May 9, 2025
High RiskFDA
Avkare
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, N...
Oral Drugs·962 affected·May 9, 2025
High RiskFDA
Kvk Tech, Inc.
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, N...
Oral Drugs·9,107 affected·May 9, 2025
High RiskFDA
Alembic Pharmaceuticals Limited
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 3...
Oral Drugs·2,946 affected·May 9, 2025
High RiskFDA
Kvk Tech, Inc.
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10...
Oral Drugs·9,680 affected·May 9, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: ...
Diagnostic Devices·1,958 affected·May 9, 2025
High RiskFDA
Bondsforever, Inc Dba Shastha Foods
Dixit Foods, Pohe, Net Wt. 110 g, Ingredients: Rice Flakes, Groundnuts, Edible Sunflower oil, Sugar, Salt, Green Chilli, Asafoetida, Curr...
Food·300 affected·May 8, 2025
High RiskFDA
Bondsforever, Inc Dba Shastha Foods
Dixit Foods, Sabudana Khichadi, Net Wt. 200 g, Ingredients: Sago (Sabudana), Crushed Groundnuts, Sugar, DesiGhee, Salt, Green Chilli, Cum...
Food·90 affected·May 8, 2025
High RiskFDA
Ohio Medical Corporation
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Respiratory Devices·36 affected·May 8, 2025
High RiskFDA
Carefusion 303, Inc.
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403...
Medical Devices·6,332 affected·May 8, 2025
High RiskFDA
Vern's Foods & Farm
Taylor Shellfish Farms Geoduck Chowder Base, frozen, Ingredients: Potatoes, Clam (Geoduck) ***Butter (Cream, Salt), Fish Sauce Ka Me***CO...
Dairy·48 affected·May 7, 2025
High RiskFDA
Alembic Pharmaceuticals Limited
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 079...
Ophthalmic Drugs·0 affected·May 7, 2025
High RiskFDA
Medtronic Minimed, Inc.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Medical Devices·1,440 affected·May 7, 2025
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: O...
Medical Devices·3,069 affected·May 7, 2025
High RiskFDA
Microaire Surgical Instruments, Llc
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal...
Medical Devices·1,451 affected·May 7, 2025
High RiskFDA
Gbc Food Services, Llc
Supreme Produce Celery & PB Snack Cup. Net Wt: 9oz (225g). Keep Refrigerated. UPC 8 50065-40308 3. GBC Food Services, 14043 Distribut...
Snacks & Candy·514 affected·May 6, 2025
High RiskFDA
Tortilleria Xpress Inc
Tortilla de mesa with 12 units per package, Tortilla Pirata with 10 units per package, Tortilla cruda especial with 20 units per package,...
Food·359 affected·May 6, 2025
High RiskFDA
Sweetheart Usa, Llc
Gluten Free Vegan Peanut Butter Jam Cookie, Net Wt. 3.5 oz (200g), packaged individually in plastic
Dairy·53 affected·May 6, 2025
High RiskFDA
Gbc Food Services, Llc
Supreme Produce Apple & PB Snack Cup. Net Wt: 8oz (226g). Keep Refrigerated. UPC 8 50065-403 1. GBC Food Services, 14043 Distribution...
Snacks & Candy·514 affected·May 6, 2025
High RiskFDA
Copan Wasp
PhenoMATRIX
Medical Devices·14 affected·May 6, 2025
High RiskFDA
Baxter Healthcare Corporation
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, ...
Medical Devices·164 affected·May 6, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Medical Devices·12,195 affected·May 5, 2025
High RiskFDA
Dexcom, Inc.
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Diabetes Devices·61,355 affected·May 5, 2025
High RiskFDA
Asp Global, Llc. Dba Anatomy Supply Partners, Llc.
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary ...
Medical Devices·4,272,858 affected·May 5, 2025
High RiskFDA
Empower Clinic Services, Llc Dba Empower Pharmacy
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam ...
Injectable Drugs·8,230 affected·May 2, 2025
High RiskFDA
Canary Medical, Inc.
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem ...
Medical Implants·106 affected·May 2, 2025
High RiskFDA
Cardinal Health 200, Llc
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Surgical Devices·370 affected·May 2, 2025
High RiskFDA
Healthmark Industries Co., Inc.
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Medical Devices·193,035 affected·May 2, 2025
High RiskFDA
Cardinal Health 200, Llc
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Surgical Devices·1,710 affected·May 2, 2025
High RiskFDA
Copan Italia
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Diagnostic Devices·81,600 affected·May 2, 2025