FDA recalls, November 2012: 505 published

146 different companies appear this month.

Risk classification: Class I: 166 · Class II: 314 · Class III: 25

Same month, other agencies:CPSC 33 recallsNHTSA 38 recalls

Recalls this month

DateProduct
November 28, 2012Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoa…Z-0379-2013Microgenics Corporation
November 28, 2012KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant …Z-0418-2013King Systems Corp.
November 28, 2012. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head …Z-0391-2013Zimmer, Inc.
November 28, 2012bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Dan…Z-0305-2013Biomerieux Inc
November 28, 2012bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, Eng…Z-0302-2013Biomerieux Inc
November 28, 2012KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult…Z-0420-2013King Systems Corp.
November 28, 2012"***Avena de Aqu¿ Si Azucar A¿adida****8oz****Fabricado por Postres de Aqui, Inc. Calle B…F-0710-2013Postres de Aqui, Inc.
November 28, 20126.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0358-2013NuVasive Inc
November 28, 20127.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0376-2013NuVasive Inc
November 28, 2012Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core…Z-0407-2013Vital Signs Colorado Inc.
November 28, 2012Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Ca…Z-0387-2013Stryker Howmedica Osteonics Corp.
November 28, 20126.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0356-2013NuVasive Inc
November 28, 2012Gilster-Mary Lee Corporation, Better Valu Fruit Whirls, Naturally Flavored packaged in a …F-0722-2013Gilster-Mary Lee Corp.
November 28, 2012Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy…D-059-2013Dr. Reddy's Laboratories, Inc.
November 28, 2012Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) …Z-0408-2013Siemens Healthcare Diagnostics, Inc.
November 28, 2012bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The pr…Z-0300-2013Biomerieux Inc
November 28, 2012Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirati…F-0715-2013Sartori Inspirations, LLC
November 28, 20126.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0374-2013NuVasive Inc
November 28, 2012Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. …Z-0431-2013Stryker Orthobiologics, Inc.
November 28, 20126.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0357-2013NuVasive Inc
November 28, 2012GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human h…Z-0199-2013GE Healthcare, LLC
November 28, 2012INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany …Z-0405-2013Carl Zeiss Meditec, Inc.
November 28, 2012The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assis…Z-0385-2013Mako Surgical Corporation
November 28, 2012bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software up…Z-0329-2013Biomerieux Inc
November 28, 2012Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L)…F-0711-2013Schoep's Ice Cream Co, Inc
November 28, 2012bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Jap…Z-0308-2013Biomerieux Inc
November 28, 2012Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For u…Z-0338-2013Superstat Corp
November 28, 201200780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slo…Z-0400-2013Zimmer, Inc.
November 28, 2012The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile …Z-0416-2013Zimmer, Inc.
November 28, 2012Grape Tomatoes, 199 cartons x 12 packages x 1 pint.F-0723-2013E.D. Produce
November 28, 2012Mango Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspiratio…F-0718-2013Sartori Inspirations, LLC
November 28, 2012S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Produc…Z-0417-2013SpineFrontier, Inc.
November 28, 2012Mediterranean Tapenade packaged in 7 oz clear plastic and 5 lb capacity white plastic tub…F-0713-2013Sartori Inspirations, LLC
November 28, 2012bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software up…Z-0327-2013Biomerieux Inc
November 28, 2012Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. …Z-0335-2013Superstat Corp
November 28, 2012bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, Eng…Z-0309-2013Biomerieux Inc
November 28, 2012. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head …Z-0393-2013Zimmer, Inc.
November 28, 201200780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slo…Z-0398-2013Zimmer, Inc.
November 28, 2012bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and…Z-0312-2013Biomerieux Inc
November 28, 2012bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The…Z-0318-2013Biomerieux Inc
November 28, 201200780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slott…Z-0395-2013Zimmer, Inc.
November 28, 2012Spinach Feta Dip packaged in 7 oz clear plastic containers, manufactured by Sartori Inspi…F-0719-2013Sartori Inspirations, LLC
November 28, 20125.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0354-2013NuVasive Inc
November 28, 2012bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software …Z-0324-2013Biomerieux Inc
November 28, 2012KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult…Z-0421-2013King Systems Corp.
November 28, 2012IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used…Z-0428-2013Innovative Magnetic Resonance Imaging Systems Inc.
November 28, 20124.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0369-2013NuVasive Inc
November 28, 20127.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0366-2013NuVasive Inc
November 28, 2012BioPlant, a dental bone grafting material. BioPlant has been assigned the product code L…Z-0401-2013Kerr Corporation
November 28, 2012Kalamata Tapenade packaged in 7 oz clear plastic and 5 lb white plastic capacity containe…F-0712-2013Sartori Inspirations, LLC

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