Skip to main content
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Diagnostic Devices·571 affected·Sep 19, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 20lb and 18lb bulk "Fifth Avenue" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 15lb bulk "Madison" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 15lb bulk "Broadway" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 20lb bulk "Park" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Egress Capital Partners Inc.
Taproom Gourmet brand 18lb bulk "Empire" Mix
Food·3,547 affected·Sep 18, 2025
High RiskFDA
Goyal Group Inc.
1. SILVER HORSE - PURE ALUMINIUM MADE IN INDIA - ALUMINIUM MILK PAN 4 inches 2. SILVER HORSE - ALUMINIUM MATHAR KADAI - 26 inches
Dairy·293 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
Ge Medical Systems, Llc
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Medical Devices·31 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed ...
Surgical Devices·48,110 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" S...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 118026441...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm...
Surgical Devices·60 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) ...
Surgical Devices·2,840 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed t...
Surgical Devices·0 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (1...
Surgical Devices·10,130 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Spring...
Surgical Devices·0 affected·Sep 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for O...
Medical Devices·833 affected·Sep 18, 2025
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Medical Devices·51,144 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP....
Medical Devices·5,770 affected·Sep 18, 2025
High RiskFDA
Ge Medical Systems, Llc
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Medical Devices·37 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PE...
Surgical Devices·2,760 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWEN...
Medical Devices·2,450 affected·Sep 18, 2025
High RiskFDA
Pepsico Inc
Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk. Outer case label reads as , "*** Lipton Green Tea Citrus (25g sugar)***" In...
Beverages·2,854 affected·Sep 17, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403...
Topical Drugs·13,824 affected·Sep 17, 2025
High RiskFDA
Park Avenue Compounding
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, ND...
Drugs·858 affected·Sep 17, 2025
High RiskFDA
Baxter Healthcare Corporation
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermomete...
Medical Devices·5,209 affected·Sep 17, 2025
High RiskFDA
Cpm Medical Consultants, Llc.
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, ...
Medical Devices·3,317 affected·Sep 17, 2025
High RiskFDA
Enterix, Inc.
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure O...
Medical Devices·201,426 affected·Sep 17, 2025
High RiskFDA
Sprout Organics Inc.
6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGAN...
Beverages·9,873 affected·Sep 16, 2025
High RiskFDA
Lawrence Wholesale Llc
Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UPC: 011110622952 Shrimp Cocktail Bowl; 17oz clear plastic retail packaging. ...
Seafood·8,400 affected·Sep 16, 2025
High RiskFDA
Lawrence Wholesale Llc
16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised...
Seafood·4,871 affected·Sep 16, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, ...
Oral Drugs·54,432 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Devices·45 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Devices·3 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological sy...
Surgical Devices·19 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Devices·3 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices·17 affected·Sep 16, 2025
High RiskFDA
Surgical Theater Inc
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Devices·50 affected·Sep 16, 2025
High RiskFDA
Severn Peanut Company Llc
MIXED NUTS Roasted & Salted NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMOND...
Food·516 affected·Sep 15, 2025
High RiskFDA
Graviti Pharmaceuticals Private Limited
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Li...
Oral Drugs·46,512 affected·Sep 15, 2025
High RiskFDA
Amerisource Health Services Llc
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Col...
Oral Drugs·360 affected·Sep 15, 2025
High RiskFDA
Alcon Research Llc
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTA...
Medical Devices·28,323 affected·Sep 15, 2025
High RiskFDA
Mars Foods Us
Ben's Original Ready Rice Long Grain & Wild, 8.8oz., UPC 0 54800 42331 6. 12 retail units per wholesale case
Food·1,075 affected·Sep 12, 2025
High RiskFDA
Mars Foods Us
Ben's Original Ready Rice Whole Grain Brown, 8.8oz., UPC 0 54800 42334 7. 12 retail units per wholesale case.
Food·315 affected·Sep 12, 2025
High RiskFDA
M.o.m Enterprises, Llc.
Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitam...
Produce·46,752 affected·Sep 12, 2025
High RiskFDA
Mars Foods Us
Ben's Original Ready Rice Original Long Grain White, 8.8oz., UPC 0 54800 42333 0. 12 retail units per wholesale case
Food·273 affected·Sep 12, 2025