FDA recalls, September 2012: 541 published

156 different companies appear this month.

Risk classification: Class I: 250 · Class II: 261 · Class III: 30

Same month, other agencies:CPSC 14 recallsNHTSA 54 recalls

Recalls this month

DateProduct
September 5, 2012Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), R…D-1667-2012Apotex Corp.
September 5, 2012Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Len…Z-2287-2012Unimed Surgical Products, Inc.
September 5, 2012Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdri…Z-2274-2012Atlas Spine, Inc.
September 5, 2012Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. T…Z-2282-2012Toshiba American Medical Systems Inc
September 5, 2012syngo Imaging XS. Radiological image processing system.Z-2264-2012Siemens Medical Solutions USA, Inc
September 5, 20123DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, …Z-2302-2012Encore Medical, Lp
September 5, 2012Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 5…Z-2283-2012Siemens Healthcare Diagnostics, Inc.
September 5, 2012Cass Clay, LIGHT CANDY BAR, half gallon (1.89 L ) 0 70422 24032 2F-2051-2012Cass Clay Creamery AMPI Fargo Division
September 5, 201216 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an A…Z-2277-2012Bard Access Systems
September 5, 2012The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, mu…Z-2281-2012Advanced Neuromodulation Systems Inc.
September 5, 2012Cass Clay, COOKIES 'N CREAM, 1 gallon ( 3.78 L), 0 70422 45034 9 Cass Clay, COOKIES 'N C…F-2037-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle…D-1671-2012Natural Essentials Inc
September 5, 2012CASS-CLAY, Ice Cream, Artificially Flavored MAPLE NUT, One Gallon (3.78 L), 0 70422 03404…F-2035-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012BUSCHS SHEPHERD'S CHICKEN PIE 14 OZF-2084-2012Busch's, Inc. - Central Production Facility
September 5, 2012Tex Mex Sliced Vegetable Blend, Item #TMEX Red Pepper, Green Pepper, Spanish Onion {1/4"…F-2076-2012Fresh Ideas Inc.
September 5, 2012Costa 1/16" Sliced Onions, 5 lb poly bag (Item # 00254); Costa 1/4" Sliced Onions, 5 lb …F-2065-2012Fresh Ideas Inc.
September 5, 2012Cass Clay CHOCOLATE MONSTER, half gallon (1.89 L) 0 70422 00032 2 Cass Clay CHOCOLATE MO…F-2048-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012Cass Clay, LIGHT MUDDY SNEAKERS, half gallon (1.89 L) 0 70422 24072 8F-2052-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor i…Z-2279-2012Mindray DS USA, Inc. d.b.a. Mindray North America
September 5, 2012Calico bean Salad 5 lbs Poly Tub (Item #01409) packaged under Costa and Stop & Shop bra…F-2073-2012Fresh Ideas Inc.
September 5, 2012Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Produc…Z-2263-2012Cisco Systems Inc
September 5, 2012Frozen Half Shell Oyster meat I.Q.F, 5x4lbs (144pieces/case).F-2102-2012Interstate Seafood Inc
September 5, 2012Wide Wedge Ham SandwichF-2023-2012Rita's Fine Food, Inc. Dba Da Vinci's
September 5, 2012Markets of Meijer, fresh Grillers, Mushrooms with Rosemary, 10 oz, Ingredients: Mushroom…F-2095-2012Pure Hothouse Foods Inc.
September 5, 2012Cass-Clay , Swiss Chip, 3 Gallon(11.34 L).F-2057-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012UNH Stir Fry: 5 lbs ply bag Broccoli. Bock Choy. Spanish Onions (1" x 1" cut). Celery …F-2064-2012Fresh Ideas Inc.
September 5, 2012POTATO CKS ORIGINAL BM 1 EAF-2082-2012Busch's, Inc. - Central Production Facility
September 5, 2012Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863…Z-2303-2012Philips Healthcare Inc.
September 5, 2012Smith's Old Fashioned Lemon Flavor Iced Tea, pasteurized, packed in 1 gallon (3.78L) cont…F-2030-2012Smith Dairy Products Co
September 5, 2012Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infus…Z-2268-2012Baxter Healthcare Corp.
September 5, 2012Sunquest Laboratory LabAccess Results Workstation (LARS)Z-2272-2012Sunquest Information Systems, Inc.
September 5, 2012Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk car…F-2109-2012Nha Trang Seafoods, Inc
September 5, 2012Cass Clay, WINTER WONDER, half gallon (1.89 L) , 0 70422 00100 8 Cass Clay, Winter Wo…F-2054-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx…D-1668-2012American Health Packaging
September 5, 2012Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., We…D-1662-2012Apotex Corp.
September 5, 2012Wegman's Gazpacho Soup 16 oz retail cup Product Code: 85631F-2106-2012Blount Seafood Corporation
September 5, 2012Costa: 1/2" Diced Onions (Item #C228); 3/4" Diced Onions (Item #C244) 1/4" Diced Onio…F-2068-2012Fresh Ideas Inc.
September 5, 20126" Turkey & Cheese Sandwich, Turkey & Cheese Triangle Sandwich, and Wide Wedge Turkey & C…F-2020-2012Rita's Fine Food, Inc. Dba Da Vinci's
September 5, 2012Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insul…Z-2293-2012Unimed Surgical Products, Inc.
September 5, 2012Schroeder, Ice Cream, Chocolate Chip Cookie Dough, half gallon (1.89 L), 0 72340 00183 2F-2055-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx onl…D-1663-2012Bracco Diagnostics Inc
September 5, 2012Wegman's Caribbean Black Bean Soup 16 oz retail cup Product Code: 85656F-2107-2012Blount Seafood Corporation
September 5, 2012Cass-Clay, UND CHAMPION CHIP, half gallon (1.89 L) 0 70422 04062 5 Cass-Clay, UND CH…F-2046-2012Cass Clay Creamery AMPI Fargo Division
September 5, 2012Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Le…Z-2294-2012Unimed Surgical Products, Inc.
September 5, 2012ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas…Z-2304-2012Sendx Medical Inc
September 5, 2012Pico de Gallo salsa, 2 lbs pouch, packaged in a case of 5/2 lbs. Product labeling reads i…F-2033-2012Real Mex Foods
September 5, 2012Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in pa…Z-2271-2012Biomet 3i, LLC
September 5, 2012PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM …Z-2285-2012Phadia US Inc
September 5, 2012CASS-CLAY, Ice cream, LIGHT MAPLE NUT, One Gallon (3.78L), 0 70422 23404 8F-2059-2012Cass Clay Creamery AMPI Fargo Division
September 5, 20121/2 PAN BAKED MOSTACCIOLI BM 1 EAF-2085-2012Busch's, Inc. - Central Production Facility

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