FDA recalls, December 2017: 188 published

102 different companies appear this month.

Risk classification: Class I: 40 · Class II: 132 · Class III: 16

Recalls this month

DateProduct
December 13, 2017Raley's Purely Made Dry Roasted Unsalted Peanuts; 12 oz. (340 g) clear plastic bag. No a…F-0426-2018New Century Snacks LLC
December 13, 2017Dark Chocolate Raisins, 16 oz.F-0419-2018Detroit City Nut, LLC
December 13, 2017Butter Pecan Ice Cream 3 gallonsF-0424-2018Working Cow Homemade Inc.
December 13, 2017Dark Chocolate Almonds, 10 oz.F-0417-2018Detroit City Nut, LLC
December 13, 2017PENTARAY NAV High-Density Mapping Catheter.Z-0211-2018Biosense Webster, Inc.
December 13, 2017Roasted & Salted Cashews and Chocolate Covered Cashews; packaged in clear plastic contain…F-0433-2018Meijer Distribution, Inc
December 13, 2017Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Labor…D-0107-2018Elite Laboratories Inc.
December 13, 2017FLAVORx Sweetening Enhancer , the product is packaged as follows: Vet Sweetening Enhan…F-0429-2018FLAVORx Inc.
December 13, 2017Krispy Kreme Doughnuts, Glazed Mini Crullers, Krispy Juniors, Manufactured under the auth…F-0451-2018krispy kreme doughnut corporation
December 13, 2017pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per b…Z-0193-2018Pro-Med Instruments Gmbh
December 13, 2017FLAVORx Sweetening Enhancer , the product is packaged as follows: Fillmaster Auto Swee…F-0428-2018FLAVORx Inc.
December 13, 2017Comforts FOR BABY Purified Water with Flouride Added. 1 GAL (3.78 L) DISTRIBUTED BY THE …F-0493-2018The Kroger Co
December 13, 2017Krispy Kreme Doughnuts, Glazed Mini Crullers, Net Wt. 10 oz, Manufactured under the autho…F-0450-2018krispy kreme doughnut corporation
December 13, 2017Krispy Kreme Doughnuts, Original Glazed Doughnut Holes, Manufactured under the authority …F-0453-2018krispy kreme doughnut corporation
December 13, 2017TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase S…Z-0196-2018Becton Dickinson & Co.
December 13, 2017Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: T…Z-0206-2018Novo Nordisk Inc
December 13, 2017PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Powe…D-0104-2018Gadget Island, Inc
December 13, 2017BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use…Z-0198-2018Becton Dickinson & Co.
December 13, 2017Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the F…Z-0203-2018Fukuda Denshi Co., Ltd.
December 13, 2017grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Gin…D-0106-2018Gadget Island, Inc
December 13, 2017Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection ho…Z-0205-2018Won Industry Co.
December 13, 2017Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) smal…Z-0208-2018Intersurgical Inc
December 13, 2017No Sugar Added Butter Pecan Ice Cream 3 gallonsF-0425-2018Working Cow Homemade Inc.
December 13, 2017Organic traditions brand DARK CHOCOLATE ALMONDS, NET WT. 3.5 oz. (100 g) - UPC 8 54260 01…F-0438-2018Health Matters America Inc.
December 13, 2017Krispy Kreme Doughnuts, Glazed Cake, Doughnut Holes, Manufactured under the authority of …F-0452-2018krispy kreme doughnut corporation
December 13, 2017FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed …D-0105-2018Gadget Island, Inc
December 13, 2017WOLDONG WORLD'S BEST KIMCHI WHOLE CABBAGE KIMCHI PREMIUM 3LBS (1.36kg), UPC: 8 46034 0485…F-0430-2018H. A. R. Maspeth Corp.
December 13, 2017RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distribut…D-0103-2018Gadget Island, Inc
December 13, 2017DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) In…Z-0199-2018DeRoyal Industries Inc
December 13, 2017Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. I…Z-0201-2018Exactech, Inc.
December 13, 2017Holi Aioli, Lemon Basil 12oz bottleF-0440-2018JP's Delicacies LLC
December 13, 2017SMARTABLATE RF System GeneratorZ-0210-2018Biosense Webster, Inc.
December 13, 2017BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles ar…Z-0207-2018Becton Dickinson & Company
December 13, 2017Krispy Kreme Doughnuts, Glazed Pumpkin Spice Cake Doughnuts, Net Wt. 13.5oz (half dozen),…F-0449-2018krispy kreme doughnut corporation
December 13, 2017Dark Chocolate Peanuts, 16 oz.F-0418-2018Detroit City Nut, LLC
December 13, 2017Cookies N Cream Ice Cream 3 gallonsF-0423-2018Working Cow Homemade Inc.
December 13, 2017Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: Internati…D-0102-2018International Laboratories, Inc.
December 13, 2017CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650…Z-0202-2018GE Medical Systems Information Technologies, Inc.
December 13, 2017Krispy Kreme Doughnuts, Glazed Blueberry Cake Doughnuts, Net Wt. 13.5oz (half dozen), Man…F-0447-2018krispy kreme doughnut corporation
December 13, 2017FLAVORx Sweetening Enhancer , the product is packaged as follows: "Sweetening Enhancer…F-0427-2018FLAVORx Inc.
December 13, 2017Saranac Pasta and Seafood Salad 2x10lbs or 2x5lbs plastic tubs.F-0514-2018Saranac Brand Foods, Inc.
December 13, 2017GOYA Adobo, All Purpose Seasoning with Pepper, Goya Foods, Inc. 28 OZF-0506-2018Tradewind Foods de Puerto Rico Inc.
December 6, 2017Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.…Z-0189-2018Volcano Corporation
December 6, 2017pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 6…F-0397-2018Pure Encapsulations, Inc.
December 6, 2017Yorgo's Foods SUNDRIED TOMATO and BASIL HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10031 5. …F-0477-2018Yorgo Food's Inc.
December 6, 2017Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perr…D-0098-2018Mayne Pharma Inc
December 6, 2017ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for …Z-0180-2018Arrow International Inc
December 6, 2017GourmetNut DARK CHOCOLATE COVERED ALMONDS NET WT 7oz (198g); UPC: 708747152203F-0381-2018Gourmet Nut, Inc.
December 6, 2017Berry Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Pr…F-0408-2018Reese Pharmaceutical Company
December 6, 2017SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Cont…Z-0191-2018CSL Behring GmbH

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