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High RiskFDA
Roi Cps Llc
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Medical Devices·228 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
Medical Devices·190 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
Medical Devices·32 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
Medical Devices·69 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
Medical Devices·160 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
Medical Devices·164 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
Medical Devices·24 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Cardiac Devices·108 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
Medical Devices·38 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
Medical Devices·177 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
Medical Devices·170 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
Medical Devices·125 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
Medical Devices·243 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
Medical Devices·790 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
Medical Devices·20 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
Medical Devices·28 affected·Oct 20, 2022
High RiskFDA
Corelink Llc
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Medical Devices·18 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
Medical Devices·204 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
Medical Devices·90 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
Medical Devices·302 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
Medical Devices·54 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit
Medical Devices·326 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
Medical Devices·38 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
Medical Devices·456 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
Medical Devices·738 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
Medical Devices·780 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
Medical Devices·30 affected·Oct 20, 2022
High RiskFDA
Coopersurgical, Inc.
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Medical Devices·220,500 affected·Oct 20, 2022
High RiskFDA
G Fuel Llc
GFUEL brand Watermelon Limeade Energy Drink; 16 fl. oz.; ready-to-drink energy beverage in a can
Beverages·48,000 affected·Oct 18, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc....
Oral Drugs·0 affected·Oct 18, 2022
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom Progressa Bed System
Medical Devices·248 affected·Oct 18, 2022
High RiskFDA
Domino Foods Inc
Domino and C&H Granulated Pure Cane Sugar Easy Baking Tub packaged in 3.5lb plastic tubs 6 tubs per case
Food·6,040 affected·Oct 17, 2022
High RiskFDA
Steris Corporation
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or w...
Surgical Devices·5 affected·Oct 17, 2022
High RiskFDA
Accelerate Diagnostics Inc
Accelerate PhenoTest BC kit REF 10101018
Medical Devices·200 affected·Oct 17, 2022
High RiskFDA
Visionsense, Ltd.
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Medical Devices·34 affected·Oct 17, 2022
High RiskFDA
River City Seafood International Llc
La Rosa Brand BluCrab Pasteurized Crabmeat (Jumbo, Lump, Claw) Peso Neto: 454g Can label art is the same for all cans, there is a stick...
Meat & Poultry·51 affected·Oct 14, 2022
High RiskFDA
Getinge Usa Sales Inc
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Medical Devices·5 affected·Oct 14, 2022
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue b...
Surgical Devices·95 affected·Oct 14, 2022
High RiskFDA
Sonendo Inc
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Medical Devices·15 affected·Oct 14, 2022
High RiskFDA
Sonendo Inc
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Medical Devices·16 affected·Oct 14, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Food·15,865,104 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
Food·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
Beverages·14,588,544 affected·Oct 13, 2022
High RiskFDA
Abbott Laboratories
Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
Food·14,588,544 affected·Oct 13, 2022