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High RiskFDA
Fhc, Inc.
microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
Medical Devices·2,952 affected·May 10, 2018
High RiskFDA
Smiths Medical Asd Inc.
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-...
Medical Devices·933,518 affected·May 10, 2018
High RiskFDA
Fhc, Inc.
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Medical Devices·2,952 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
Medical Devices·200 affected·May 10, 2018
High RiskFDA
Life Technologies, Corp.
Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.
Medical Devices·6 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
Medical Devices·7 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
Medical Devices·17 affected·May 10, 2018
High RiskFDA
Fhc, Inc.
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Medical Devices·2,952 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
Medical Devices·246 affected·May 10, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
RS 5F DL XPP KIT, Catalog Number 60M183104
Medical Devices·5 affected·May 10, 2018
High RiskFDA
Johnson & Johnson Surgical Vision Inc
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 441062...
Medical Devices·9 affected·May 9, 2018
High RiskFDA
B. Braun Medical, Inc.
Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresit...
Medical Devices·1,872 affected·May 9, 2018
High RiskFDA
Sugarfina, Llc
Sugarfina Sugar Cookies Distributed by Sugarfina, Inc. small candy cube, large candy cube, and 1.0oz. taster packet UPC Code: 84027810...
Bakery & Grains·33,609 affected·May 8, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Sp...
Medical Devices·122,889 affected·May 8, 2018
High RiskFDA
Exactech, Inc.
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature indiv...
Medical Devices·1 affected·May 8, 2018
High RiskFDA
Dynarex Corporation
Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressur...
Respiratory Devices·15 affected·May 8, 2018
High RiskFDA
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic ...
Medical Devices·790 affected·May 8, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Bax...
Medical Devices·333,961 affected·May 8, 2018
High RiskFDA
Zeiss, Carl Inc
Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. La...
Medical Devices·1,070 affected·May 8, 2018
High RiskFDA
Medtech Sas
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is in...
Surgical Devices·29 affected·May 8, 2018
High RiskFDA
Rij Pharmaceutical Llc
Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Ve...
Drugs·31,411 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 F...
Drugs·5,043 affected·May 7, 2018
High RiskFDA
Perrigo New York
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 490...
Topical Drugs·571,632 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL A...
Drugs·1,272 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 ...
Drugs·13,380 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middlet...
Drugs·1,505 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1...
Supplements·8,124 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MID...
Drugs·228 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bo...
Drugs·0 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 1120...
Drugs·21,213 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ ...
Drugs·9,240 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwic...
Drugs·3,537 affected·May 7, 2018
High RiskFDA
Rij Pharmaceutical Llc
Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp....
Drugs·12,756 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Medical Devices·1,752 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
Medical Devices·372 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
Medical Devices·144 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
Medical Devices·1,020 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
Medical Devices·432 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
Medical Devices·456 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
Medical Devices·276 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Medical Devices·15,180 affected·May 7, 2018
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test st...
Diabetes Devices·295,248 affected·May 7, 2018
High RiskFDA
Ethicon, Inc.
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
Medical Devices·4,452 affected·May 7, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS Sodium Slides, Catalog # 837 9034
Medical Devices·0 affected·May 5, 2018
High RiskFDA
The C.f. Sauer Company
Code - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene t...
Food·5 affected·May 4, 2018
High RiskFDA
The C.f. Sauer Company
Premium - Recipe Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. poly...
Food·2 affected·May 4, 2018
High RiskFDA
The C.f. Sauer Company
Sauer - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene ...
Food·53 affected·May 4, 2018
High RiskFDA
The C.f. Sauer Company
Pocahontas - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethy...
Food·3 affected·May 4, 2018