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High RiskFDA
Raysearch Laboratories Ab
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Medical Devices·213 affected·Mar 28, 2024
High RiskFDA
Raysearch Laboratories Ab
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Medical Devices·18 affected·Mar 28, 2024
High RiskFDA
Nortera Foods Usa
Wegmans brand Frozen Cut Green Beans; 16oz bags
Frozen Food·5,200 affected·Mar 27, 2024
High RiskFDA
Pueblo Fruits, Inc.
Onion Yellow Med 3 Outer Rings 4-5 LB in a 5 LB ,vacuum sealed, clear plastic bag. Labeling: White paper label with the following informa...
Produce·23 affected·Mar 27, 2024
High RiskFDA
Natco Pharma Limited
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured b...
Oral Drugs·30 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Medical Devices·202 affected·Mar 27, 2024
High RiskFDA
Newport Corp
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply al...
Medical Devices·19 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Medical Devices·64 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Medical Devices·2,905 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Medical Devices·98 affected·Mar 27, 2024
High RiskFDA
Cardinal Health 200, Llc
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Medical Devices·128 affected·Mar 27, 2024
High RiskFDA
Shawnee Milling Company
5 lb.Food Club All Purpose Flour Best if Used by 03/08/2025
Food·3,360 affected·Mar 26, 2024
High RiskFDA
Cipla Usa, Inc.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 via...
Drugs·59,244 affected·Mar 26, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Gl...
Oral Drugs·6,528 affected·Mar 26, 2024
High RiskFDA
Surgical Specialties
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Medical Devices·2,459 affected·Mar 26, 2024
High RiskFDA
Baxter Healthcare Corporation
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUET...
Medical Devices·11,154 affected·Mar 26, 2024
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 0880...
Oral Drugs·2,784 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·0 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·1 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·107 affected·Mar 25, 2024
High RiskFDA
Ossur H / F
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Medical Implants·143 affected·Mar 25, 2024
High RiskFDA
The Coastal Companies Dba Hearn Kirkwood
Egg salad sandwich packaged in clamshell for individual sale. 7.22oz (205g) UPC 766375938415
Produce·551 affected·Mar 23, 2024
High RiskFDA
Integradose Compounding Services Llc
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Min...
Injectable Drugs·187 affected·Mar 22, 2024
High RiskFDA
B. Braun Medical Inc
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Injectable Drugs·7,800 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
Medical Devices·0 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOW...
Cardiac Devices·26,096 affected·Mar 22, 2024
High RiskFDA
Ebi, Llc
48" Lead Wires, Replacement Part Number: 1067724-4
Medical Devices·594 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
Medical Devices·0 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DY...
Surgical Devices·22,891 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYN...
Medical Devices·6,998 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
Medical Devices·316,125 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984...
Medical Devices·75,098 affected·Mar 22, 2024
High RiskFDA
Ebi, Llc
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary ...
Medical Devices·0 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
Medical Devices·160 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
Medical Devices·88,703 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
Medical Devices·1,700 affected·Mar 22, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
Medical Devices·99 affected·Mar 22, 2024
High RiskFDA
Shearer's Foods, Llc
Great Value Twist & Shout Strawberry Creme Sandwich Cookies, Net WT 15.35 oz. box containing film wrapped trays of stacked cookies. 12 bo...
Bakery & Grains·112 affected·Mar 21, 2024
High RiskFDA
Amy's Kitchen Inc.
Amy's Kitchen Enchilada Verde Whole Meal 10 oz. 12 pk Item # 000085
Food·8,563 affected·Mar 21, 2024
High RiskFDA
Tradewind Foods De Puerto Rico Inc.
Goya Red Kidney Beans, Net Wt.15.5oz.(439g), metal (tin) cans, 24 cans/15.5 oz. per case
Food·1,349 affected·Mar 21, 2024
High RiskFDA
Apothecus Pharmaceutical Corp.
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp...
Drugs·17,280 affected·Mar 21, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufac...
Oral Drugs·26,352 affected·Mar 21, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis ze...
Medical Devices·583 affected·Mar 21, 2024
High RiskFDA
Belgian Yummies
Belgian Yummies Homemade Ice Cream Birthday Cake Gelato. Packaged in 5 Liter gray carapina liner.
Dairy·31 affected·Mar 20, 2024
High RiskFDA
Belgian Yummies
Belgian Yummies Homemade Ice Cream Strawberry Gelato. Packaged in 5 Liter gray carapina liner.
Dairy·53 affected·Mar 20, 2024
High RiskFDA
Ontact Inc
24K Premium Lense, Distributed by Updream Inc.
Medical Devices·2,842 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary in...
Medical Devices·0 affected·Mar 20, 2024
High RiskFDA
Zimmer, Inc.
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of ost...
Medical Devices·0 affected·Mar 20, 2024