Skip to main content
High RiskFDA
Integra Lifesciences Corp.
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·27 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·161 affected·Jan 19, 2024
High RiskFDA
W.l. Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Cat...
Medical Implants·24 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·30 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·188 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the br...
Medical Devices·4 affected·Jan 19, 2024
High RiskFDA
Unfi General Corporate
Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Golden Flax. Net Wt. 18.5 oz (1 lb 2.5 oz) 524g. UPC 0 42563-01772 9. Distrib...
Bakery & Grains·73,872 affected·Jan 18, 2024
High RiskFDA
Whitley Peanut Factory, Inc.
Whitley's Peanut Factory, Deluxe Nut Mix, 12oz (340g), Electrolytic tin-plated cans, with paper label. 12-pack case boxes.
Food·840 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ...
Oral Drugs·11,400 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, I...
Oral Drugs·14,568 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical...
Oral Drugs·10,690 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufac...
Oral Drugs·1,728 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, N...
Oral Drugs·9,408 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury...
Oral Drugs·15,768 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbur...
Oral Drugs·6,552 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufa...
Oral Drugs·19,992 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufac...
Oral Drugs·55,272 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, ...
Oral Drugs·1,220 affected·Jan 18, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed b...
Oral Drugs·54,504 affected·Jan 18, 2024
High RiskFDA
Henry Schein Inc. And Glove Club Hsi Gloves Inc.
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, V...
Injectable Drugs·1,099 affected·Jan 17, 2024
High RiskFDA
Convatec, Inc
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Surgical Devices·1,715 affected·Jan 17, 2024
High RiskFDA
Alfred Louie Inc
Pan Fry Noodle Fresh Noodles, Alfred Louie, Inc. 24 Lb. cartons, Keep Refrigerated. Deep Fry Noodle Fresh Noodles, Alfred Louie, Inc. 40L...
Food·550 affected·Jan 16, 2024
High RiskFDA
Den-mat Holdings, Llc
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-20...
Oral Drugs·10,103 affected·Jan 16, 2024
High RiskFDA
Den-mat Holdings, Llc
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LL...
Oral Drugs·344 affected·Jan 16, 2024
High RiskFDA
Ascend Laboratories, Llc
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: ...
Oral Drugs·71,244 affected·Jan 16, 2024
High RiskFDA
Maquet Medical Systems Usa
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Cardiac Devices·16,520 affected·Jan 16, 2024
High RiskFDA
Olympus Corporation Of The Americas
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contaminati...
Medical Devices·877 affected·Jan 16, 2024
High RiskFDA
Maquet Medical Systems Usa
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Cardiac Devices·16,520 affected·Jan 16, 2024
High RiskFDA
Olympus Corporation Of The Americas
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS15...
Diagnostic Devices·102,279 affected·Jan 16, 2024
High RiskFDA
W&h Dentalwerk Buermoos Gmbh
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Surgical Devices·160 affected·Jan 16, 2024
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Soli...
Oral Drugs·858 affected·Jan 15, 2024
High RiskFDA
D.o.r.c. Dutch Opthalmic Research Center Intl B.v.
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Medical Devices·13 affected·Jan 15, 2024
High RiskFDA
Medical Action Industries, Inc. 306
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Medical Devices·206,200 affected·Jan 15, 2024
High RiskFDA
D.o.r.c. Dutch Opthalmic Research Center Intl B.v.
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
Medical Devices·21 affected·Jan 15, 2024
High RiskFDA
8th Ave Pharmacy
Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIONAL PLAZA 20 SHEU...
Baby Food & Formula·5,600 affected·Jan 14, 2024
High RiskFDA
Wegmans Food Markets, Inc.
24ct Petite Pastry Tray, plastic tray with white base and clear lid (not a scale label) (UPC: UPC 7789034215)
Bakery & Grains·10,338 affected·Jan 12, 2024
High RiskFDA
Wegmans Food Markets, Inc.
Ready To Bake Chocolate and Almond Variety Pk (UPC 87-85300-05013-0)
Snacks & Candy·10,338 affected·Jan 12, 2024
High RiskFDA
Wegmans Food Markets, Inc.
9 oz 10pk Assorted Mini Danish, bakery box with clear top (UPC 7789050815)
Food·10,338 affected·Jan 12, 2024
High RiskFDA
Wegmans Food Markets, Inc.
Ready To Bake Double Chocolate Croissant (UPC 87-85300-05006-2)
Snacks & Candy·10,338 affected·Jan 12, 2024
High RiskFDA
United Natural Trading Inc. Dba Woodstock Farms
Market Basket, Organic Trek Mix, 11oz & 14oz. plastic resealable bags . 8/11oz & 12/14oz bags per case.
Food·48 affected·Jan 12, 2024
High RiskFDA
Golden State Medical Supply Inc.
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC...
Oral Drugs·108 affected·Jan 12, 2024
High RiskFDA
Integradose Compounding Services Llc
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Drugs·281 affected·Jan 12, 2024
High RiskFDA
Greco Sidari
GRANDE 1.5OZ FRESH BOCCONCINI MOZZ 1/3# SUPC/ITEM # 19132P
Food·1,375 affected·Jan 11, 2024
High RiskFDA
Greco Sidari
SAPUTO STELLA ASGO HLF MLD 11LB SUPC/ITEM # 19009
Food·1,375 affected·Jan 11, 2024
High RiskFDA
Greco Sidari
SOFINA 21202 MASTRO CAPOCOLLC 4 - 6LB SUPC/ITEM # 199694
Food·1,375 affected·Jan 11, 2024
High RiskFDA
Greco Sidari
GRANDE SOPRAFFINA RICOTTA 1/30# SUPC/ITEM # 19536
Food·1,375 affected·Jan 11, 2024
High RiskFDA
Greco Sidari
AURICCHIO IMP SHARP PROV CHEESE 1/17# SUPC/ITEM # 197110
Dairy·1,375 affected·Jan 11, 2024
High RiskFDA
Greco Sidari
BEL GIOIOSO PEPATO ASIAGO CON PEPPERCORN 10-8OZ SUPC/ITEM # 53478
Food·1,375 affected·Jan 11, 2024