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High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIR...
Medical Devices·1,236 affected·Nov 21, 2024
High RiskFDA
Abbott Medical
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which oper...
Medical Implants·7,295 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833...
Medical Devices·3,903 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
Medical Devices·1,494 affected·Nov 21, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
Medical Devices·80 affected·Nov 21, 2024
High RiskFDA
Joseph Epstein Food Enterprises, Inc. Dba Mamamancini's
Mama Mancini s Stuffed Shells with Sauce and Mozzarella Cheese, 4 packs of 4 lbs. each / 6 packs of 14 oz. each, 4 packs/boxes per case /...
Dairy·1,170 affected·Nov 20, 2024
High RiskFDA
Joseph Epstein Food Enterprises, Inc. Dba Mamamancini's
Hungryroot Ricotta Stuffed Shells, 6 packs of 14 oz. each, plastic trays
Food·1,170 affected·Nov 20, 2024
High RiskFDA
Michael Zakany Llc
Jose Madrid Salsa Chipotle Con Queso, Net Wt. 13 oz. (369g), packaged in glass jars; 12 jars per case
Snacks & Candy·438 affected·Nov 20, 2024
High RiskFDA
Philips North America Llc
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Medical Devices·4,811 affected·Nov 20, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·1,664 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·205 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man...
Oral Drugs·2,835 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·690 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·988 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·1,133 affected·Nov 19, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottl...
Oral Drugs·233,003 affected·Nov 19, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 572...
Oral Drugs·122,925 affected·Nov 19, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, ...
Oral Drugs·209,376 affected·Nov 19, 2024
High RiskFDA
Olympus Corporation Of The Americas
Duravent Silicone Ventilation Tube. Model Number: 240075.
Respiratory Devices·984 affected·Nov 19, 2024
High RiskFDA
Med Michigan Holding Llc
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove exce...
Cardiac Devices·109 affected·Nov 19, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Medical Devices·1 affected·Nov 19, 2024
High RiskFDA
Greiner Bio-one Gmbh
VACUETTE SAFELINK, REF: 450210
Medical Devices·188,800 affected·Nov 19, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10...
Oral Drugs·9,828 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10...
Oral Drugs·65,169 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10)...
Oral Drugs·42,331 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10...
Oral Drugs·92,512 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10...
Oral Drugs·55,032 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10...
Oral Drugs·35,883 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10...
Oral Drugs·19 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10...
Oral Drugs·118,324 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10)...
Oral Drugs·43,765 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10)...
Oral Drugs·63,077 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10)...
Oral Drugs·34,845 affected·Nov 18, 2024
High RiskFDA
Ge Medical Systems, Llc
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Medical Devices·644 affected·Nov 18, 2024
High RiskFDA
Ge Medical Systems, Llc
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Medical Devices·8,319 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Medical Devices·1,464 affected·Nov 18, 2024
High RiskFDA
Beckman Coulter, Inc.
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) ...
Cardiac Devices·2,109,804 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
Medical Devices·250 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Medical Devices·768 affected·Nov 18, 2024
High RiskFDA
Elucent Medical Inc
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushio...
Medical Devices·283 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Medical Devices·360 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Medical Devices·1,332 affected·Nov 18, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder n...
Surgical Devices·749 affected·Nov 18, 2024
High RiskFDA
Philips North America Llc
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Medical Devices·301 affected·Nov 16, 2024
High RiskFDA
Northern Tier Bakery Llc
7-Eleven Chicken Salad Sandwich, UPC 7 63913-79486 1. Net Wt. 7.0 oz (198g), Keep Refrigerated. Mfg By: Supermom's St. Paul Park, MN ...
Meat & Poultry·220 affected·Nov 15, 2024
High RiskFDA
Impossible Foods Inc
Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case
Meat & Poultry·32,536 affected·Nov 15, 2024
High RiskFDA
Impossible Foods Inc
Impossible Savory Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02108 8; 8 retail chubs per case
Meat & Poultry·46,413 affected·Nov 15, 2024
High RiskFDA
Evaric Pharmaceuticals Inc.
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber P...
Oral Drugs·222 affected·Nov 15, 2024