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High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: O...
Medical Devices·738 affected·Sep 13, 2024
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of t...
Medical Devices·209 affected·Sep 13, 2024
High RiskFDA
Integra Lifesciences Corp.
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (M...
Medical Devices·120,124 affected·Sep 13, 2024
CriticalFDA
Zyno Medical Llc
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.0...
Medical Devices·34,994 affected·Sep 13, 2024
RecallFDA
Berkeley Club Beverages, Inc.
Berkeley Springs Water Purified , Berkeley Springs Water Distilled , One Gallons & Five Gallons, Plastic, 6 gallons in one case and1 indi...
Beverages·1,304 affected·Sep 12, 2024
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Medical Devices·13,318 affected·Sep 12, 2024
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Medical Devices·15,068 affected·Sep 12, 2024
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4...
Respiratory Devices·10,957 affected·Sep 12, 2024
High RiskFDA
Lemonland Food Corp
Item FLD1040A, Wild Leeks, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Wild Leeks, Sugar, S...
Food·3 affected·Sep 11, 2024
RecallFDA
Lemonland Food Corp
Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, ...
Seafood·10 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD2011, Salted and Seasoned Small Octopus, distributed in plastic clamshell containers, net wt. 0.267lb. The H-Mart label declares...
Produce·70 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD1080A, Seasoned Radish, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Radish, Red Pep...
Food·30 affected·Sep 11, 2024
RecallFDA
Lemonland Food Corp
Item FLD1010A, Seasoned Peanut, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Peanut, Soy Sau...
Food·15 affected·Sep 11, 2024
RecallFDA
Lemonland Food Corp
Item FLD1000AA, Seasoned Sesame Leaves or Seasoned Perilla Leaves, distributed in plastic clamshell containers, net wt. 0.315lb. The H-M...
Produce·15 affected·Sep 11, 2024
High RiskFDA
Lemonland Food Corp
Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares ...
Food·20 affected·Sep 11, 2024
High RiskFDA
Lemonland Food Corp
Item FLD1015A, Stewed Lotus Root, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Lotus Root, S...
Food·25 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD1070A, Seasoned Dandelion, distributed in plastic clamshell containers. Net wt. 0.365lb. The H-Mart label declares: Dandelion, S...
Food·10 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD1020A, Seasoned Pepper with Soybean Paste, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declar...
Food·6 affected·Sep 11, 2024
RecallFDA
Lemonland Food Corp
Item FLD1004A, Seasoned Dried Whiting, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Dried Po...
Food·10 affected·Sep 11, 2024
CriticalFDA
Lemonland Food Corp
Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise...
Produce·120 affected·Sep 11, 2024
High RiskFDA
Zhejiang Jingwei Pharmaceutical Co., Ltd.
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Di...
Topical Drugs·295,164 affected·Sep 11, 2024
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halo...
Injectable Drugs·5 affected·Sep 11, 2024
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Ophthalmic Drugs·27 affected·Sep 11, 2024
High RiskFDA
Medtronic Neuromodulation
SynchroMed II Infusion Pump. Product Number: 8637-20
Medical Devices·1 affected·Sep 11, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 6105...
Medical Devices·14,093 affected·Sep 11, 2024
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Medical Devices·32 affected·Sep 11, 2024
High RiskFDA
Coca Cola Consolidated Llc
Minute Maid Zero Sugar Lemonade 12 cans carton UPC 0 25000 12115 9 CANNED UNDER THE AUTHORITY OF THE COCA-COLA COMPANY, ATLANTA, GA
Food·13,152 affected·Sep 10, 2024
High RiskFDA
Avole, Inc.
Bacalaitos Criollos, CODFISH FRYING MIX, 7 oz., packaged in a plastic bag, 24 packages (units) per cases of 7 onz.
Seafood·100 affected·Sep 9, 2024
High RiskFDA
Kent Precision Foods Group, Inc.
1. Sqwincher Electrolyte Beverage Mix, orange powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025004; packaged in assorted cas...
Beverages·1,231 affected·Sep 9, 2024
High RiskFDA
Kent Precision Foods Group, Inc.
Sqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item nu...
Beverages·251 affected·Sep 9, 2024
CriticalFDA
Innovation Bakers, Llc
7-Eleven Fudge Brownie with Chocolate Chip, 3.5 oz. UPC: 05254856392
Snacks & Candy·2,081 affected·Sep 9, 2024
High RiskFDA
Atrium Medical Corporation
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Medical Implants·11 affected·Sep 9, 2024
High RiskFDA
Hydration Labs Inc. Dba Bevi
Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single u...
Beverages·1,611 affected·Sep 6, 2024
CriticalFDA
Gorilla Mind Llc
Gorilla Mind Rauwolscine Dietary Supplement, Suppress Appetite, Increased Fat Loss, Increased Energy, dosage 3mg, 90 capsules per bottle,...
Supplements·1,348 affected·Sep 6, 2024
High RiskFDA
Enchroma Inc
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SU...
Medical Devices·53 affected·Sep 6, 2024
High RiskFDA
Agfa Healthcare Nv
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-...
Diagnostic Devices·801 affected·Sep 6, 2024
High RiskFDA
Shimadzu Corporation Medical Systems Division
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including ...
Medical Devices·3 affected·Sep 6, 2024
CriticalFDA
Eagle Produce Llc, Dba Martori Farms
Whole cantaloupe, brand name Kandy, packed in a corrugated box, 9 count
Food·224 affected·Sep 5, 2024
High RiskFDA
Empower Pharmacy
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empowe...
Injectable Drugs·450 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive dis...
Cardiac Devices·6 affected·Sep 5, 2024
High RiskFDA
Beckman Coulter, Inc.
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobu...
Diagnostic Devices·465,481 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive displ...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Luminex Molecular Diagnostics Inc
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Respiratory Devices·613 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provid...
Cardiac Devices·9 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide p...
Cardiac Devices·161 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display ...
Cardiac Devices·2 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to pro...
Cardiac Devices·58 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive dis...
Cardiac Devices·5 affected·Sep 5, 2024