Skip to main content
High RiskFDA
Ibsa Pharma Inc
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. b...
Oral Drugs·0 affected·Jan 30, 2023
High RiskFDA
Ibsa Pharma Inc
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. b...
Oral Drugs·0 affected·Jan 30, 2023
High RiskFDA
Carestream Health, Inc.
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to a...
Diagnostic Devices·72 affected·Jan 30, 2023
High RiskFDA
Diasorin Molecular Llc
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Diagnostic Devices·90,142 affected·Jan 30, 2023
High RiskFDA
Carefusion 2200 Inc
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG...
Medical Devices·5,952 affected·Jan 30, 2023
High RiskFDA
Pepsico Inc
Starbucks frappuccino Vanilla. Chilled Coffee Drink. 13.7 Fl Oz (405mL). UPC 0 12000-81331 3. Starbucks Coffee Company. For comments ...
Beverages·25,200 affected·Jan 28, 2023
High RiskFDA
Amerisource Health Services Llc
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health...
Oral Drugs·422 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plas...
Diagnostic Devices·11,824 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (li...
Diagnostic Devices·8,420 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithi...
Diagnostic Devices·13,071 affected·Jan 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithiu...
Diagnostic Devices·5,315 affected·Jan 27, 2023
High RiskFDA
Coopervision, Inc.
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Medical Devices·24 affected·Jan 26, 2023
High RiskFDA
Coopervision, Inc.
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Diagnostic Devices·4 affected·Jan 26, 2023
High RiskFDA
Joy Joys Bakery Llc
Ube Spanish Bread, UPC 36897113. Product is packaged in plastic clear clamshell container and there are 6 pieces per container. Ingredie...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
Vietnamese Coffee Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37080 7.
Dairy·21 affected·Jan 25, 2023
High RiskFDA
Joy Joys Bakery Llc
Ube Ensaymada, UPC 6658266481. Product is packaged in plastic clear clamshell container and there are 4 pieces per container. Ingredients...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
Coconut Pandan Cheesecake Coconut Butter Biscuit Crust (4oz) - 6 60845 37071 5.
Dairy·23 affected·Jan 25, 2023
High RiskFDA
Alpenland International, Inc.
HEILEMANN CONFISERIE WEHNACHTSFIGUREN AUS EDELVOLLMILCH-SCHOKOLADE Solid Chocolate Holiday Treats 3.5 oz box UPC 4006574007199
Snacks & Candy·220 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
Ube (Purple Yam) Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37067 8. Ube (Purple Yam) Cheesecake Coconut Butter Biscuit...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Joy Joys Bakery Llc
Ube Roll UPC 35961092. Product is packaged in plastic clear clamshell container and there are 3 pieces per container. Ingredients: Ube F...
Dairy·10 affected·Jan 25, 2023
High RiskFDA
Amlag & Quibuyen, Llc Dba Hood Famous Bake Shop
White Chocolate Guava Cheesecake Coconut Butter Biscuit Crust (4oz) - UPC 6 60845 37077 7.
Dairy·35 affected·Jan 25, 2023
High RiskFDA
Church & Dwight Inc
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text ...
Medical Devices·780,000 affected·Jan 25, 2023
High RiskFDA
Limacorporate S.p.a
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Medical Devices·5 affected·Jan 25, 2023
High RiskFDA
Stryker Corporation
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Medical Devices·88 affected·Jan 25, 2023
High RiskFDA
Stryker Corporation
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimati...
Medical Devices·541 affected·Jan 25, 2023
High RiskFDA
Bake'n Joy Foods, Inc.
Gordon Choice Cranberry Orange Flavored Nut muffin batter; 8lbs; packaged in pails
Produce·436 affected·Jan 24, 2023
High RiskFDA
Carefusion 303, Inc.
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Medical Devices·83,185 affected·Jan 24, 2023
High RiskFDA
Intuitive Surgical, Inc.
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, ...
Surgical Devices·9 affected·Jan 24, 2023
High RiskFDA
United States Bakery Dba Franz Bakery
Kirkland Signature 18 Sandwich Rolls Ideal for Hot Dogs, net wt. 54 oz. UPC 0 96619 49013 4. Product is ambient does not require special ...
Food·66 affected·Jan 20, 2023
High RiskFDA
Medtronic Neuromodulation
SenSight Connector Plug, Model Number B31061.
Medical Devices·65 affected·Jan 20, 2023
High RiskFDA
Coltene Whaledent Inc
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation...
Medical Devices·3,896 affected·Jan 20, 2023
High RiskFDA
Linet Spol. S.r.o.
Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Medical Devices·335 affected·Jan 18, 2023
High RiskFDA
Niagara Bottling
Limited Edition Winter Mint Chocolate Premier Protein 30g Protein High Protein Shake 11.5oz (340mL) UPC 00643843801498 packaged in plasti...
Snacks & Candy·288 affected·Jan 17, 2023
High RiskFDA
Fisher Scientific Co., Llc
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher ...
Drugs·1,077 affected·Jan 17, 2023
High RiskFDA
Fisher Scientific Co., Llc
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceu...
Topical Drugs·106 affected·Jan 17, 2023
High RiskFDA
Urban Electric Power
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
Inhaled / Nasal Drugs·609 affected·Jan 17, 2023
High RiskFDA
Urban Electric Power
Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles...
Drugs·239 affected·Jan 17, 2023
High RiskFDA
Preferred Pharmaceuticals, Inc.
Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., ...
Oral Drugs·9 affected·Jan 16, 2023
High RiskFDA
Hologic, Inc.
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3...
Medical Devices·797 affected·Jan 16, 2023
High RiskFDA
Fujifilm Irvine Scientific, Inc.
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Medical Devices·15,131 affected·Jan 16, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20...
Medical Devices·6 affected·Jan 16, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc.
SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
Medical Devices·4 affected·Jan 16, 2023
High RiskFDA
Sun Pharmaceutical Industries Inc
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries...
Oral Drugs·3,120 affected·Jan 13, 2023
High RiskFDA
Nephron Sc Inc
S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By...
Drugs·925,920 affected·Jan 13, 2023
High RiskFDA
Nephron Sc Inc
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, ...
Drugs·387,000 affected·Jan 13, 2023
High RiskFDA
Summit Medical, Llc
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Medical Devices·30 affected·Jan 13, 2023
High RiskFDA
Ortho Molecular Products, Inc.
Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following brands and sizes. 1. Ortho Molecular Products F...
Beverages·4,929 affected·Jan 12, 2023
High RiskFDA
Accord Healthcare, Inc.
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by:...
Oral Drugs·87,576 affected·Jan 12, 2023