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High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compan...
Ophthalmic Drugs·8,747 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·8,000 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·8,810 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company,...
Ophthalmic Drugs·8,868 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Compan...
Topical Drugs·16,500 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indian...
Topical Drugs·282,564 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs·83,898 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Com...
Topical Drugs·8,819 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company,...
Ophthalmic Drugs·196,111 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Comp...
Ophthalmic Drugs·8,873 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, ...
Topical Drugs·180,315 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc...
Ophthalmic Drugs·5,509 affected·Sep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company...
Ophthalmic Drugs·293,400 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
LAVH, REF BBLV21C
Medical Devices·18 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack SAH, REF SAR530M
Medical Devices·96 affected·Sep 1, 2023
High RiskFDA
Onkos Surgical, Inc.
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight...
Medical Devices·147 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack, REF SJVO56B
Medical Devices·112 affected·Sep 1, 2023
High RiskFDA
Onkos Surgical, Inc.
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, ...
Medical Devices·233 affected·Sep 1, 2023
High RiskFDA
Onkos Surgical, Inc.
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-0...
Medical Devices·120 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Vasc. Open CVOR SJH, REF SJVO56B
Medical Devices·84 affected·Sep 1, 2023
High RiskFDA
Convergent Dental
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Surgical Devices·39 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
CVS PCSU SJH, REF SJCV48J
Medical Devices·36 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Pediatric Heart SJH, REF SJPH34K
Cardiac Devices·72 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Cath Cardiac Pack, REF IHCC03V
Cardiac Devices·1,260 affected·Sep 1, 2023
High RiskFDA
Angel Medical Systems, Inc.
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a car...
Medical Implants·548 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Robotics Pack, REF SSRO22D
Medical Devices·56 affected·Sep 1, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectr...
Medical Devices·3,470 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Sub Q Recorder Pack, REF BPRC87A
Medical Devices·96 affected·Sep 1, 2023
High RiskFDA
Fox Confections Llc
F-Bombs Cookie Dough Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018032
Bakery & Grains·150 affected·Aug 31, 2023
High RiskFDA
Fox Confections Llc
F-Bombs Original Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018001
Food·126 affected·Aug 31, 2023
High RiskFDA
Fox Confections Llc
F-Bombs Cookies & Cream Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018025
Dairy·122 affected·Aug 31, 2023
High RiskFDA
Fox Confections Llc
F-Bombs Raspberry Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018124
Produce·150 affected·Aug 31, 2023
High RiskFDA
Killer Brownie Ltd
US Foods: Peanut Butter Toffee Bar, 3.4oz unit size, packaged in flow wrap, 24 packages per case
Dairy·82,080 affected·Aug 31, 2023
High RiskFDA
Fox Confections Llc
F-Bombs S'Mores Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018155
Food·126 affected·Aug 31, 2023
High RiskFDA
Pulmonx, Corp.
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Medical Devices·144 affected·Aug 31, 2023
High RiskFDA
Philips North America Llc
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product C...
Medical Devices·13 affected·Aug 31, 2023
High RiskFDA
Access Vascular, Inc
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Medical Devices·58 affected·Aug 31, 2023
High RiskFDA
Access Vascular, Inc
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Medical Devices·58 affected·Aug 31, 2023
High RiskFDA
Smith & Nephew Inc
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Medical Devices·8 affected·Aug 31, 2023
High RiskFDA
Southern Taiwan Llc
Radish Turnip Cake (w/o shrimp): The product comes in a 900g ( 32 ounce), clear plastic package marked with UPC # 425404904110. Ingredie...
Seafood·40 affected·Aug 30, 2023
High RiskFDA
Vistapharm Llc
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPhar...
Oral Drugs·14,400 affected·Aug 30, 2023
High RiskFDA
Ab Sciex, Llc
Citrine Triple Quad Mass Spectrometer, Part Number 5063684
Medical Devices·14 affected·Aug 30, 2023
High RiskFDA
Ab Sciex, Llc
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Medical Devices·38 affected·Aug 30, 2023
High RiskFDA
Royalvibe Health Ltd.
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, Royal...
Medical Devices·564 affected·Aug 30, 2023
High RiskFDA
Coopersurgical, Inc.
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Tho...
Medical Devices·127 affected·Aug 29, 2023
High RiskFDA
Becton Dickinson Infusion Therapy Systems Inc.
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Surgical Devices·98,000 affected·Aug 29, 2023
High RiskFDA
Arjohuntleigh Polska Sp. Z.o.o.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module...
Medical Devices·83 affected·Aug 29, 2023
High RiskFDA
Arjohuntleigh Polska Sp. Z.o.o.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module...
Medical Devices·846 affected·Aug 29, 2023