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Recall Observatory FDA recall evidence

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Recalled products

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86,536 products

Page 3448 of 3462

Product Firm Event Initiated
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. The Anspach Effort, Inc. Event 65863 May 06, 2011
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. The Anspach Effort, Inc. Event 65863 May 06, 2011
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone The Anspach Effort, Inc. Event 65863 May 06, 2011
Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. BRAEMAR, INC. Event 65423 May 02, 2011
Mother's Milk Bank at Austin, Batch # 8638-1, 3 oz.(100 mL), Pasteurized, Exp: 02/19/2012, Kcal/Oz: 24, Protein: 0.9 g/dl. Mothers' Milk Bank at Austin Event 62998 May 02, 2011
Mother's Milk Bank at Austin, Batch # 78501-1, 3 oz.(100 mL), Pasteurized, Exp: 06/28/2011, Kcal/Oz: 22, Protein: 1.0 g/dl. Mothers' Milk Bank at Austin Event 62998 May 02, 2011
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization. Cardiogenesis Corporation Event 66046 May 01, 2011
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Sunquest Information Systems, Inc. Event 62344 April 28, 2011
Approximately 5 lb plastic bucket of Conch Fritter Batter labeled in part: "***NEPTUNE'S CONCH FRITTERS ALL NATURAL***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice, Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166*** Net Weight 5 lbs.*** Triton Seafood Co. Event 62889 April 28, 2011
Approximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: "***NEPTUNE'S CONCH FRITTERS PRECOOKED***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166***Pack: 125 Units Net Wt. 5# (approx.)*** Triton Seafood Co. Event 62889 April 28, 2011
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures. Extremity Medical LLC Event 62918 April 25, 2011
#1 Gluten Free brand White Cake Mix, 5 lb., UPC 6 54367 43505 2. Raymond Hadley Corporation Event 58653 April 19, 2011
#1 Gluten Free brand Chocolate Cake Mix, Net Wt: 5 lb., UPC 6 54367 43530 4 Raymond Hadley Corporation Event 58653 April 19, 2011
better batter brand CHOCOLATE MIX, A GLUTEN FREE BAKING MIX, 18.25 oz (517 g), UPC 8 96439 00209 4. The mix is packaged in a chip board box. Raymond Hadley Corporation Event 58653 April 19, 2011
better batter brand YELLOW CAKE MIX, A GLUTEN FREE BAKING MIX, 18.25 oz. (517 g), UPC 8 96439 00210 0. The mix is packaged in a chip board box. Raymond Hadley Corporation Event 58653 April 19, 2011
better batter brand Gluten Free Pancake & Biscuit Mix packaged in chip board box, in 20 oz. (UPC 8 96439 00207 0) and in 2.5 lb sizes (UPC 8 96439 00203 2). The 20 oz. product is labeled in part, "*** better batter PANCAKE & BISCUIT MIX *** 20 OZ *** UPC 8 96439 00207 0***". The 2.5 lb. product is labeled in part, "*** better batter gluten free pancake/biscuit mix *** 2.5 lb ***. Raymond Hadley Corporation Event 58653 April 19, 2011
Mrs. Bridges Scottish Raspberry Preserve ("Jam"); Net Wt. 42g /1.5oz; service size 15g; servings per package: 2.8; ID 3779300377 Manufactured for: Kimm & Miller (UK) Ltd. mille Road, Bedford, MK429TW. United Kingdom; Manufacturer: Mackays Ltd., James Chalmers Road, Kirkton Ind Estate, Arbroath, Scotland UK DD113LR. The TJX Companies, Inc. Event 64600 April 14, 2011
IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist. Extremity Medical LLC Event 62916 April 13, 2011
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1. Physicians Total Care, Inc. Event 62924 April 08, 2011
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1. Physicians Total Care, Inc. Event 62924 April 08, 2011
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1. Physicians Total Care, Inc. Event 62924 April 08, 2011
Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. Physicians Total Care, Inc. Event 65269 April 06, 2011
Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50 VistaPharm, Inc. Event 62893 April 06, 2011
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. GE Healthcare, LLC Event 65333 April 05, 2011
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. Zimmer, Inc. Event 62110 April 01, 2011