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High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box,...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
T R Toppers, Inc.
TR Toppers Brand Chopped Chocolate Pretzel Pieces. Item number B160-075 GTIN 0 06 51844 10599 6, 7.5 Lbs. (3 x 2.5 Lbs. Bags), Best Kept ...
Snacks & Candy·5,160 affected·Jun 8, 2018
High RiskFDA
Ingenus Pharmaceuticals Llc
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceu...
Injectable Drugs·34,964 affected·Jun 8, 2018
High RiskFDA
Ingenus Pharmaceuticals Llc
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceut...
Injectable Drugs·14,089 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: pro...
Medical Devices·13,503 affected·Jun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 1070503120...
Medical Devices·756 affected·Jun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705...
Medical Devices·72 affected·Jun 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Medical Implants·12 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product...
Medical Devices·107 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: ...
Medical Devices·21,971 affected·Jun 8, 2018
High RiskFDA
Bio-rad Laboratories, Inc
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory...
Medical Devices·5,212 affected·Jun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G...
Medical Devices·4,992 affected·Jun 8, 2018
High RiskFDA
Zimmer Biomet, Inc.
ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
Medical Implants·12 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Prod...
Medical Devices·305 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: pr...
Medical Devices·2,421 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Prod...
Medical Devices·6,269 affected·Jun 8, 2018
High RiskFDA
Bio-rad Laboratories, Inc
MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests...
Medical Devices·3,632 affected·Jun 8, 2018
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCI...
Medical Devices·5,200 affected·Jun 7, 2018
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED ...
Medical Devices·5,200 affected·Jun 7, 2018
High RiskFDA
House Of Spices Orlando
LAXMI Corn Flour Fine Net Wt./Poids Net. 2LB (907g) Distributed by: House of Spices (India) Inc.
Food·30 affected·Jun 6, 2018
High RiskFDA
Pharmalucence, Inc.
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box...
Drugs·95 affected·Jun 6, 2018
High RiskFDA
Pharmedium Services, Llc
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
Drugs·2,800 affected·Jun 5, 2018
High RiskFDA
Stryker Neurovascular
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE...
Medical Implants·11,585 affected·Jun 5, 2018
High RiskFDA
Four Link Nutriworld
BLUEBERRY PRETZEL, NET WEIGHT : 4OZ (113g) ,USE BY DATE : 12/1/2018
Produce·30 affected·Jun 4, 2018
High RiskFDA
Neomed Inc
NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The pr...
Medical Devices·208,260 affected·Jun 4, 2018
High RiskFDA
Cryolife, Inc.
BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achiev...
Surgical Devices·855 affected·Jun 4, 2018
High RiskFDA
Fx Solutions
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the trea...
Medical Devices·131 affected·Jun 4, 2018
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in en...
Surgical Devices·3,108 affected·Jun 4, 2018
High RiskFDA
B. Braun Medical, Inc.
26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
Medical Devices·12,320 affected·Jun 4, 2018
High RiskFDA
Nakanishi Inc.
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typ...
Medical Implants·12 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Ty...
Medical Implants·18 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are int...
Medical Implants·1,662 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are i...
Medical Implants·440 affected·Jun 1, 2018
High RiskFDA
Nakanishi Inc.
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are int...
Medical Implants·2,419 affected·Jun 1, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Injectable Drugs·941,496 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Injectable Drugs·267,288 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Injectable Drugs·1,247,200 affected·May 31, 2018
High RiskFDA
Apotex Inc.
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, ...
Inhaled / Nasal Drugs·0 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Injectable Drugs·525,984 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Injectable Drugs·88,960 affected·May 31, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
HEB Creamy Creations Orange & Cream Swirl Sherbet quart
Dairy·58,758 affected·May 30, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
HEB Creamy Creations No Sugar Added Orange Sherbet quart
Food·12,906 affected·May 30, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
HEB Creamy Creations No Sugar Added Strawberry Sherbet quart
Produce·18,630 affected·May 30, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
HEB Creamy Creations Strawberry & Cream Swirl Sherbet quart
Dairy·23,268 affected·May 30, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
EconoMax Vanilla, 4 quarts and 56 ounces
Food·68,458 affected·May 30, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
HEB Creamy Creations Rainbow Sherbet quart
Food·39,606 affected·May 30, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
Hill Country Fare Chocolate 4.5 quarts
Snacks & Candy·4,920 affected·May 30, 2018
High RiskFDA
H-e-b Grocery Company Lp Dba Heb
Hill Country Fare Cookies and Cream 56 ounces
Dairy·20,784 affected·May 30, 2018