Skip to main content
High RiskFDA
Plum Inc
Plum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA...
Dairy·81,347 affected·Jul 19, 2013
High RiskFDA
Csm Bakery Products North America
10-inch Supreme Chocolate Layered Cake; 12 units per shipping case
Bakery & Grains·6,400 affected·Jul 19, 2013
High RiskFDA
Plum Inc
Plum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Org...
Dairy·81,347 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Medical Devices·1,501 affected·Jul 19, 2013
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinica...
Diagnostic Devices·929 affected·Jul 19, 2013
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical u...
Diagnostic Devices·311 affected·Jul 19, 2013
High RiskFDA
Blue Belt Technologies Mn
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device ...
Medical Devices·60 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Medical Devices·95,286 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Medical Devices·32,834 affected·Jul 19, 2013
High RiskFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of...
Medical Devices·62 affected·Jul 19, 2013
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical u...
Diagnostic Devices·486 affected·Jul 19, 2013
High RiskFDA
Olam Tomato Processors, Inc.
Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is p...
Produce·12,870 affected·Jul 18, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Pr...
Medical Devices·179 affected·Jul 18, 2013
High RiskFDA
Vital Signs Devices, A Ge Healthcare Company
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Ca...
Medical Devices·12,239 affected·Jul 18, 2013
High RiskFDA
Mike's Quality Meats, Inc.
Frozen Hot Smoked Vacuum Packed Salmon
Seafood·65 affected·Jul 17, 2013
High RiskFDA
Apotex Inc.
Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured f...
Oral Drugs·4,844 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxid...
Medical Devices·217 affected·Jul 17, 2013
High RiskFDA
Integra Limited
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggle...
Medical Devices·65 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Steri...
Medical Devices·13,223 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01...
Medical Devices·758 affected·Jul 17, 2013
High RiskFDA
Arrow International Inc
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access ...
Surgical Devices·4,285 affected·Jul 17, 2013
High RiskFDA
Hospira Inc.
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Fo...
Medical Devices·3,560 affected·Jul 17, 2013
High RiskFDA
Beckman Coulter Inc.
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for d...
Medical Devices·68,116 affected·Jul 17, 2013
High RiskFDA
Arrow International Inc
Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Surgical Devices·170 affected·Jul 17, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstructi...
Medical Devices·506 affected·Jul 16, 2013
High RiskFDA
Aesculap, Inc.
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Surgical Devices·217 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·8 affected·Jul 16, 2013
High RiskFDA
Assuramed
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Prod...
Diagnostic Devices·10 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Assuramed
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATE...
Diagnostic Devices·1 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·7 affected·Jul 16, 2013
High RiskFDA
Hemocue Ab
HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay...
Diagnostic Devices·10,356 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH &...
Medical Devices·4 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·8 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Zimmer, Inc.
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bon...
Medical Implants·1,710 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·9 affected·Jul 16, 2013
High RiskFDA
Brainlab Ag
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & C...
Medical Devices·4 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by...
Medical Devices·81 affected·Jul 15, 2013
High RiskFDA
Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by...
Medical Devices·9 affected·Jul 15, 2013