Skip to main content
High RiskFDA
Ergosafe Products, Llc (dba) Prism Medical
Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model number...
Medical Devices·17,964 affected·Aug 30, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (...
Diagnostic Devices·5 affected·Aug 30, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with...
Medical Devices·200 affected·Aug 29, 2016
High RiskFDA
Smith & Nephew, Inc.
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 7132...
Medical Devices·2,352 affected·Aug 29, 2016
High RiskFDA
Smith & Nephew, Inc.
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044,...
Medical Devices·5,806 affected·Aug 29, 2016
High RiskFDA
Ldr Spine Usa, Inc.
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the RO...
Surgical Devices·24 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog N...
Medical Devices·153 affected·Aug 29, 2016
High RiskFDA
Trimed Inc
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm t...
Surgical Devices·30 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with ...
Medical Devices·75 affected·Aug 29, 2016
High RiskFDA
Westby Coop Creamery
4% cottage cheese packaged in 16-ounce, 22-ounce, and 24-ounce plastic containers; under the Westby, Food Club, Oberweis, and Shurfine br...
Dairy·695 affected·Aug 27, 2016
High RiskFDA
Victory General Foods Inc
ELDER PAINTSIL'S GA KENKEY, NET WT. 1.20, UPC: 6 61799 58166 0, MANUFACTURED BY VICTORY GENERAL FOODS IN WORCESTER, MA 01603
Food·0 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of ...
Medical Implants·131 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
Medical Devices·88 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the vis...
Medical Implants·217 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of ...
Medical Implants·10 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia...
Medical Implants·84 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
Medical Devices·63 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in ...
Medical Implants·1 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
Medical Devices·69 affected·Aug 26, 2016
High RiskFDA
The Anspach Effort, Inc.
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Medical Devices·177 affected·Aug 26, 2016
High RiskFDA
Abbott Medical Optics Inc. (amo)
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual co...
Medical Implants·41 affected·Aug 26, 2016
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Centr...
Medical Devices·316 affected·Aug 25, 2016
High RiskFDA
Merit Medical Systems, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Medical Devices·1,297 affected·Aug 25, 2016
High RiskFDA
Natus Medical Incorporated
The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-S...
Medical Devices·104 affected·Aug 25, 2016
High RiskFDA
United Nuclear Scientific Supplies, Llc
United Nuclear Scientific High Power Handheld Lasers. Laser products
Medical Devices·3 affected·Aug 25, 2016
High RiskFDA
Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibi...
Medical Devices·798 affected·Aug 25, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·666 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·867 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·221 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·115 affected·Aug 24, 2016
High RiskFDA
Sandoz Inc
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deer...
Topical Drugs·42,740 affected·Aug 24, 2016
High RiskFDA
Sandoz Inc
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758...
Injectable Drugs·1,584 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·834 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·761 affected·Aug 24, 2016
High RiskFDA
Sandoz Inc
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758...
Injectable Drugs·32,099 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Sin...
Oral Drugs·126 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·1,416 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·156 affected·Aug 24, 2016
High RiskFDA
Amerisource Health Services
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts ...
Oral Drugs·2,276 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs ...
Medical Devices·320 affected·Aug 24, 2016
High RiskFDA
Philips Medical Systems
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b...
Medical Devices·358 affected·Aug 24, 2016
High RiskFDA
R & D Systems, Inc.
R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentratio...
Diagnostic Devices·725 affected·Aug 24, 2016
High RiskFDA
Azer Scientific, Inc.
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral ...
Diabetes Devices·426 affected·Aug 24, 2016
High RiskFDA
Philips Medical Systems
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b...
Medical Devices·235 affected·Aug 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 103...
Diagnostic Devices·177 affected·Aug 24, 2016
High RiskFDA
Icu Medical, Inc.
Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access de...
Surgical Devices·476,600 affected·Aug 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), U...
Diagnostic Devices·359 affected·Aug 24, 2016
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Medical Devices·710 affected·Aug 24, 2016