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High RiskFDA
Aniara Diagnostica Llc
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Diagnostic Devices·51 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006...
Medical Devices·473 affected·Jul 19, 2019
High RiskFDA
Philips North America, Llc
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedsi...
Medical Devices·280 affected·Jul 19, 2019
High RiskFDA
Ge Healthcare, Llc
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-931...
Medical Devices·502 affected·Jul 19, 2019
High RiskFDA
Stryker Corporation
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Medical Devices·73 affected·Jul 19, 2019
High RiskFDA
Integra Lifesciences Corp.
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neur...
Surgical Devices·125 affected·Jul 19, 2019
High RiskFDA
Boston Scientific Corporation
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Medical Devices·1 affected·Jul 19, 2019
CriticalFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm FDR Go Plus mobile X-ray system
Medical Devices·174 affected·Jul 19, 2019
CriticalFDA
Mountain Rose Inc. Dba Mountain Rose Herbs
Fennel Whole Seed was packaged in a clear plastic bag or poly-woven bags sold in bulk form, net weight ranges from 4 ounces to 50 pounds,...
Food·552 affected·Jul 18, 2019
High RiskFDA
National Frozen Foods Corporation
Great Value Chopped Spinach, packed in poly bags, net wt. 12 oz. 12 oz. bag UPC: 0 78742 23740 4. master case UPC: 3 00 78742 23740...
Beverages·3,124 affected·Jul 18, 2019
RecallFDA
Sunshine Bottling Co, Inc.
Sunchy Malta Pasteurized Non-Alcoholic Cereal Beverage in 7oz bottles 4 or 6/pack
Bakery & Grains·2,406 affected·Jul 18, 2019
High RiskFDA
Preferred Pharmaceuticals, Inc
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitro...
Topical Drugs·171 affected·Jul 18, 2019
RecallFDA
Amneal Pharmaceuticals, Inc.
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Oral Drugs·2,256 affected·Jul 18, 2019
High RiskFDA
Ucb, Inc
Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Oral Drugs·2,088 affected·Jul 18, 2019
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-...
Injectable Drugs·139,680 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Medical Devices·1 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas c513 Analyzer
Medical Devices·2 affected·Jul 18, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 ...
Medical Devices·19 affected·Jul 18, 2019
High RiskFDA
Thermo Fisher Scientific (monterrey)
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Medical Devices·514,200 affected·Jul 18, 2019
High RiskFDA
Arrow International Inc
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Pr...
Surgical Devices·745 affected·Jul 18, 2019
High RiskFDA
Thermo Fisher Scientific (monterrey)
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
Medical Devices·2,979,600 affected·Jul 18, 2019
High RiskFDA
Imprimisrx Nj
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 We...
Ophthalmic Drugs·246 affected·Jul 17, 2019
High RiskFDA
Macleods Pharma Usa Inc
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 coun...
Oral Drugs·5,448 affected·Jul 17, 2019
High RiskFDA
Imprimisrx Nj
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledge...
Ophthalmic Drugs·405 affected·Jul 17, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, In...
Oral Drugs·39,216 affected·Jul 17, 2019
RecallFDA
Lupin Pharmaceuticals Inc.
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Ba...
Topical Drugs·33,939 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
Medical Devices·27 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max StaphSR; Catalog # 443418
Medical Devices·283 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max ExK DNA 1 USA; Catalog # 442817
Medical Devices·115 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit EXT Enteric Bacterial Panel; Catalog # 443812
Medical Devices·715 affected·Jul 17, 2019
High RiskFDA
Owen Mumford Usa, Inc.
Autoject EI, REF AJ1310
Medical Devices·1,510 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Medical Devices·130 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Enteric Viral Panel EU Catalog # 443985
Medical Devices·469 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max ExK TNA 2; Catalog # 442825
Medical Devices·86 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
Medical Devices·447 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max MRSA; Catalog # 442953
Medical Devices·176 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Vaginal Panel; Catalog # 443712
Medical Devices·666 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
Medical Devices·10 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max StaphSR; Catalog # 443419
Medical Devices·207 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max CT/GC/TV; Catalog # 442970
Medical Devices·913 affected·Jul 17, 2019
High RiskFDA
Becton Dickinson & Co.
Kit BD Max Cdiff EU; Catalog # 442555
Medical Devices·4 affected·Jul 17, 2019
High RiskFDA
Owen Mumford Usa, Inc.
Petfine Auto Injector, REF 3310VET
Medical Devices·140 affected·Jul 17, 2019
High RiskFDA
Diversified Foods And Seasonings Llc
Macaroni and Cheese packaged in 4 lb plastic bags, 12 bags per case, frozen
Dairy·1,371 affected·Jul 16, 2019
CriticalFDA
The Crystal Spoon Corp.
Top Chef Meals Grilled Bison Burger best used by date between 5/4/19-6/30/19 Unit Size: 6 and 8 oz sizes Container Description: Pl...
Food·485 affected·Jul 16, 2019
High RiskFDA
Jelly Belly
Jelly Belly Licorice Bridge Mix. Net Wt. 9 oz. (85g); 12 individual 3 oz. bags per caddy UPC: 071567981675 Manufactured by Jelly ...
Food·223 affected·Jul 16, 2019
High RiskFDA
Deva Holding As - Cerkezkoy Subesi
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufact...
Oral Drugs·5,052 affected·Jul 16, 2019
High RiskFDA
Deva Holding As - Cerkezkoy Subesi
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufact...
Oral Drugs·13,752 affected·Jul 16, 2019
High RiskFDA
Deva Holding As - Cerkezkoy Subesi
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactu...
Oral Drugs·11,376 affected·Jul 16, 2019