FDA recalls, July 2014: 556 published

180 different companies appear this month.

Risk classification: Class I: 55 · Class II: 464 · Class III: 37

Same month, other agencies:FSIS 7 recallsNHTSA 98 recalls

Recalls this month

DateProduct
July 2, 2014Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to autom…Z-1867-2014Siemens Healthcare Diagnostics, Inc.
July 2, 2014FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Cul…Z-1843-2014BioFire Diagnostics, Inc.
July 2, 2014Navitas Naturals Organic Sprouted Chia Powder, 8 oz (227g) package; Omega Fatty Acids, P…F-2045-2014Navitas, LLC., dba Navitas Naturals
July 2, 2014ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Onl…Z-1893-2014The Anspach Effort, Inc.
July 2, 2014SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriG…Z-1848-2014SteriGear, LLC
July 2, 2014ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolub…Z-1894-2014The Anspach Effort, Inc.
July 2, 2014HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1813-2014Nitinol Devices and Components, Inc.
July 2, 2014IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical…Z-1874-2014Zynex Medical, Inc.
July 2, 2014ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device…Z-1904-2014The Anspach Effort, Inc.
July 2, 2014ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Spee…Z-1899-2014The Anspach Effort, Inc.
July 2, 2014ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intende…Z-1919-2014The Anspach Effort, Inc.
July 2, 2014Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stry…Z-1872-2014Stryker Endoscopy
July 2, 2014Ingenia 3.0T, magnetic resonance imaging system.Z-1864-2014Philips Medical Systems, Inc.
July 2, 2014ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only**…Z-1913-2014The Anspach Effort, Inc.
July 2, 2014NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 La…Z-1856-2014NxStage Medical, Inc.
July 2, 2014ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This devic…Z-1877-2014The Anspach Effort, Inc.
July 2, 2014Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems…Z-1928-2014Alere San Diego, Inc.
July 2, 2014Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to …Z-1852-2014Spacelabs Healthcare Inc
July 2, 2014Ingenia 1.5T, magnetic resonance imaging system.Z-1865-2014Philips Medical Systems, Inc.
July 2, 2014ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intend…Z-1898-2014The Anspach Effort, Inc.
July 2, 2014Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versio…Z-1845-2014Siemens Medical Solutions USA, Inc
July 2, 2014ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to…Z-1906-2014The Anspach Effort, Inc.
July 2, 2014Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number…Z-1868-2014Integra LifeSciences Corp.
July 2, 2014HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1819-2014Nitinol Devices and Components, Inc.
July 2, 2014Navitas Naturals Omega Blend Sprouted Smoothie Mix, 8 oz. (227g) package; Dietary Fiber…F-2046-2014Navitas, LLC., dba Navitas Naturals
July 2, 2014ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***R…Z-1910-2014The Anspach Effort, Inc.
July 2, 2014Ingenia 3.0T R5, magnetic resonance imaging system.Z-1862-2014Philips Medical Systems, Inc.
July 2, 2014Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distri…D-1409-2014Pfizer Us Pharmaceutical Group
July 2, 2014UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. …Z-1828-2014Beckman Coulter Inc.
July 2, 2014ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This …Z-1917-2014The Anspach Effort, Inc.
July 2, 2014ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is in…Z-1902-2014The Anspach Effort, Inc.
July 2, 2014ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended …Z-1879-2014The Anspach Effort, Inc.
July 2, 2014MAS Omni Immune ControlsZ-1929-2014Microgenics Corporation
July 2, 2014GreenSmoothieGirl TriOmega Superfood, GreenSmoothieGirl Sprouted Ground TriIOmega Superfo…F-2050-2014Green Smoothie Girl
July 2, 2014ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is …Z-1875-2014The Anspach Effort, Inc.
July 2, 2014HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1823-2014Nitinol Devices and Components, Inc.
July 2, 2014NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 La…Z-1857-2014NxStage Medical, Inc.
July 2, 2014ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device …Z-1890-2014The Anspach Effort, Inc.
July 2, 2014Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components …Z-1830-2014Beckman Coulter Inc.
July 2, 2014NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 La…Z-1859-2014NxStage Medical, Inc.
July 2, 2014HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1818-2014Nitinol Devices and Components, Inc.
July 2, 2014HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Ni…Z-1816-2014Nitinol Devices and Components, Inc.
July 2, 2014Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instru…Z-1841-2014SeaSpine Inc
July 2, 2014ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device…Z-1886-2014The Anspach Effort, Inc.
July 2, 2014Ingenia 1.5T R5, magnetic resonance imaging system.Z-1863-2014Philips Medical Systems, Inc.
July 2, 2014ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx …Z-1914-2014The Anspach Effort, Inc.
July 2, 2014ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This dev…Z-1878-2014The Anspach Effort, Inc.
July 2, 2014HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. …Z-1815-2014Nitinol Devices and Components, Inc.
July 2, 2014Dark Old Fashioned Sponge Candy, sold under the following brand and sizes: 1. Eillien's…F-2051-2014Eillien's Candies, Inc.
July 2, 2014GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces, 15% New Wt. 25 lbs. GSF LLC, Visal…F-2026-2014GSF Nut Company LLC

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