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, 2012Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral …Z-0389-2013Zimmer, Inc.
November 28, 2012KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size …Z-0424-2013King Systems Corp.
November 28, 2012Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured f…D-060-2013Ranbaxy Inc.
November 28, 20120.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentra…Z-0430-2013Biomerieux Inc
November 28, 20127.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0378-2013NuVasive Inc
November 28, 2012Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MA…Z-0380-2013Stryker Spine
November 28, 2012Jalapeno Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartor…F-0717-2013Sartori Inspirations, LLC
November 28, 2012KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child…Z-0419-2013King Systems Corp.
November 28, 20127.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0361-2013NuVasive Inc
November 28, 201200789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Pr…Z-0394-2013Zimmer, Inc.
November 28, 2012Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x …Z-0297-2013Biomet 3i, LLC
November 28, 2012The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. …Z-0414-2013Kerr Corporation
November 28, 2012GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographi…Z-0197-2013GE Healthcare, LLC
November 28, 201200789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Pr…Z-0390-2013Zimmer, Inc.
November 28, 2012Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC …F-0705-2013Swanson Health Products, Inc
November 28, 2012Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I M…Z-0381-2013Stryker Spine
November 28, 2012Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30…Z-0333-2013Superstat Corp
November 28, 2012Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For …Z-0337-2013Superstat Corp
November 28, 2012Pimento Cheese packaged in 7 oz clear plastic containers, manufactured by Sartori Inspira…F-0716-2013Sartori Inspirations, LLC
November 28, 2012bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, …Z-0323-2013Biomerieux Inc
November 28, 2012bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mou…Z-0311-2013Biomerieux Inc
November 28, 20126.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0359-2013NuVasive Inc
November 28, 2012UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. Th…Z-0346-2013Beckman Coulter Inc.
November 28, 2012Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For u…Z-0336-2013Superstat Corp
November 28, 2012bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Cze…Z-0306-2013Biomerieux Inc
November 28, 2012Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the a…Z-0386-2013Zimmer, Inc.
November 28, 2012IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Custom…Z-0344-2013Extremity Medical LLC
November 28, 2012Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. …Z-0340-2013Superstat Corp
November 28, 2012Rudi's Organic Bakery, Cinnamon Raisin, 24 oz, UPC 031493-92183-1, packed in flexible pla…F-0697-2013Charter Baking Company
November 28, 201200780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slo…Z-0397-2013Zimmer, Inc.
November 28, 2012bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, …Z-0314-2013Biomerieux Inc
November 28, 2012SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Cha…Z-0434-2013Sentec AG
November 28, 2012"Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored…F-0709-2013Postres de Aqui, Inc.
November 28, 2012bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software updat…Z-0321-2013Biomerieux Inc
November 28, 2012bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software up…Z-0328-2013Biomerieux Inc
November 28, 2012bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lit…Z-0307-2013Biomerieux Inc
November 28, 2012bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The p…Z-0320-2013Biomerieux Inc
November 28, 201200780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slo…Z-0399-2013Zimmer, Inc.
November 28, 2012ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON …Z-0292-2013Ethicon, Inc.
November 28, 20126.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0375-2013NuVasive Inc
November 28, 2012Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. …Z-0331-2013Superstat Corp
November 28, 2012Tex Mex Smoked Gouda packaged in 7 oz clear plastic containers, manufactured by Sartori I…F-0714-2013Sartori Inspirations, LLC
November 28, 2012bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software up…Z-0326-2013Biomerieux Inc
November 28, 20126.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0355-2013NuVasive Inc
November 28, 20125.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0371-2013NuVasive Inc
November 28, 2012SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COU…Z-0382-2013Stryker Spine
November 28, 2012KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size…Z-0425-2013King Systems Corp.
November 28, 20127.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0362-2013NuVasive Inc
November 28, 2012Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 …D-062-2013American Enterprises LLC dba Sterling Gelatin
November 28, 20125.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIZ-0352-2013NuVasive Inc

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