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All Product Recalls
49,195 recalls from FDA (high severity)
High RiskFDA
Spinefrontier, Inc.
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Medical Devices4 affectedDec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Medical Devices6 affectedDec 19, 2014
High RiskFDA
Mckesson Israel Ltd.
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage inf...
Medical Devices9 affectedDec 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 86...
Medical Devices10,013 affectedDec 19, 2014
High RiskFDA
Sunrise Medical (us) Llc
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Medical Devices6 affectedDec 19, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi...
Medical Devices69,725 affectedDec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Medical Devices6 affectedDec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
Medical Devices6 affectedDec 19, 2014
High RiskFDA
Angiodynamics
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6....
Medical Devices43 affectedDec 19, 2014
High RiskFDA
Ge Healthcare
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Medical Devices13 affectedDec 19, 2014
High RiskFDA
Vitony Bakery, Inc.
Guava filled pastry ("Pastelillo de Guayaba" in Spanish) 2.5 oz and 10 oz.
Bakery & Grains204 affectedDec 18, 2014
High RiskFDA
Tai Foong U.s.a., Inc
The package reads in part "***Northern Chef***GLUTEN FREE, OVEN READY LIGHTLY COATED COD***KEEP FROZEN/DO NOT REFREEZE***NET WT 10 OZ.(28...
Frozen Food861 affectedDec 18, 2014
High RiskFDA
Sysmex Corporation
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use...
Diagnostic Devices1,137 affectedDec 18, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Medical Devices103 affectedDec 18, 2014
High RiskFDA
Spinal Elements, Inc
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Pati...
Medical Devices1,200 affectedDec 18, 2014
High RiskFDA
St Jude Medical Cardiac Rhythm Management Division
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Medical Devices257,456 affectedDec 18, 2014
High RiskFDA
Ziemer Usa Inc
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Surgical Devices26 affectedDec 18, 2014
High RiskFDA
Tovli, Inc.
Vegi-Chef Potato Knishes retail pack 1 lb. 8 oz. (680g), UPC 046676-91114-1
Food445 affectedDec 17, 2014
High RiskFDA
Neolpharma, Inc.
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 0...
Injectable Drugs12,310 affectedDec 17, 2014
High RiskFDA
Tropichem Research Labs, Inc.
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
Drugs24,348 affectedDec 17, 2014
High RiskFDA
Zimmer Gmbh
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur i...
Medical Devices1,908 affectedDec 17, 2014
High RiskFDA
Zimmer Gmbh
Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint d...
Medical Devices16 affectedDec 17, 2014
High RiskFDA
Zimmer Gmbh
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femu...
Medical Devices30 affectedDec 17, 2014
High RiskFDA
Aesculap, Inc.
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ...
Medical Devices772 affectedDec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bear...
Medical Implants1,051 affectedDec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for no...
Medical Implants1,051 affectedDec 17, 2014
High RiskFDA
Zimmer Gmbh
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for re...
Medical Devices6,109 affectedDec 17, 2014
High RiskFDA
Zimmer Gmbh
Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem comp...
Medical Devices10,340 affectedDec 17, 2014
High RiskFDA
Stryker Craniomaxillofacial Division
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implan...
Medical Implants1,051 affectedDec 17, 2014
High RiskFDA
Jaymac Pharmaceuticals L.l.c.
J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufac...
Drugs5,572 affectedDec 16, 2014
High RiskFDA
Arrow International Inc
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Mu...
Surgical Devices420 affectedDec 16, 2014
High RiskFDA
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PL...
Medical Devices838 affectedDec 16, 2014
High RiskFDA
Leica Microsystems, Inc.
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is...
Diagnostic Devices309 affectedDec 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software ...
Medical Devices7 affectedDec 16, 2014
High RiskFDA
Tricar Sales Inc
Organic English Cucumber, 12 pieces per box, PLU 94593, UPC 8 24660 20100 9
Food3,462 affectedDec 15, 2014
High RiskFDA
Schwan Food Company Dba Holiday Foods
Hors D'Oeuvre, Holiday Foods¿ Breaded Macaroni and Cheese Bites with Quattro Formaggi Cheese, Lobster & Truffle Oil (item number 4802732)...
Dairy27 affectedDec 15, 2014
High RiskFDA
Schwan Food Company Dba Holiday Foods
Hors D'Oeuvre, Holiday Foods¿ Breaded Macaroni & Cheese Bites (item number 4802280). UPC 70220748022808, Keep Frozen, For Institutional U...
Dairy60 affectedDec 15, 2014
High RiskFDA
Actavis Elizabeth Llc
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101,...
Oral Drugs24,240 affectedDec 15, 2014
High RiskFDA
Actavis Elizabeth Llc
Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Ma...
Oral Drugs10,857 affectedDec 15, 2014
High RiskFDA
Actavis Elizabeth Llc
Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Ma...
Oral Drugs29,622 affectedDec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Diagnostic Devices59,965 affectedDec 15, 2014
High RiskFDA
Synthes, Inc.
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used i...
Medical Devices1,762 affectedDec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Diagnostic Devices32,159 affectedDec 15, 2014
High RiskFDA
Nordicneurolab As
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limite...
Diagnostic Devices16 affectedDec 15, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic syst...
Diagnostic Devices11 affectedDec 15, 2014
High RiskFDA
Genetic Testing Institute,inc
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13...
Diagnostic Devices6,206 affectedDec 15, 2014
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
Diagnostic Devices31,799 affectedDec 15, 2014
High RiskFDA
American Specialty Pharmacy
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999...
Injectable Drugs15 affectedDec 12, 2014