FDA recalls, September 2015: 317 published

59 different companies appear this month.

Risk classification: Class I: 62 · Class II: 246 · Class III: 9

Recalls this month

DateProduct
September 16, 2015Black Walnut Divinity Ice Cream Bucket, 373, Jeni's Splendid Ice Creams, LLC, 3 gallons, …F-3093-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Wildberry Lavender Ice Cream Bucket, 327, Jeni's Splendid Ice Creams, LLC, 3 gallons, pla…F-3151-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Black Currant Lambic Sorbet Bucket, 385, Jeni's Splendid Ice Creams, LLC, 3 gallons, plas…F-3187-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Raspberry Red Currant, Brioche and Jam Bucket, 316, Jeni's Splendid Ice Creams, LLC, 3 ga…F-3125-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 4280…Z-2752-2015Intuitive Surgical, Inc.
September 16, 2015The Buckeye State Ice Cream Bucket, 309, Jeni's Splendid Ice Creams, LLC, 3 gallons, plas…F-3144-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Black Currant Frozen Yogurt Bucket, 305, Jeni's Splendid Ice Creams, LLC, 3 gallons, plas…F-3167-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceu…D-1420-2015Mutual Pharmaceutical Company, Inc.
September 16, 2015Snowy Coconut Macaroon Ice Cream Sandwich Case, 515, Jeni's Splendid Ice Creams, LLC, 6oz…F-3201-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model nu…Z-2751-2015Intuitive Surgical, Inc.
September 16, 2015Buttercup Pumpkin w/Amaretti Cookies Ice Cream Bucket, 304, Jeni's Splendid Ice Creams, L…F-3099-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Brown Butter Almond Brittle Ice Cream Bucket, 308, Jeni's Splendid Ice Creams, LLC, 3 gal…F-3098-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, ind…F-3221-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Bitter Lemon Ice Bucket, 816, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket,…F-3191-2015Jeni's Splendid Ice Creams LLC
September 16, 2015Blackout Terrine Slice, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, individually…F-3225-2015Jeni's Splendid Ice Creams LLC
September 9, 2015MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgical proce…Z-2609-2015Customed, Inc
September 9, 2015LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient …Z-2677-2015Customed, Inc
September 9, 2015UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS Used by medical staff to perform surgical…Z-2583-2015Customed, Inc
September 9, 2015Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottl…D-1406-2015Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
September 9, 2015Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Produc…Z-2732-2015C.R. Bard, Inc.
September 9, 2015FACE PACK MRT 8/CS CUSTOMED Used by medical staff to perform surgical procedures and …Z-2650-2015Customed, Inc
September 9, 2015LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patie…Z-2601-2015Customed, Inc
September 9, 2015Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray…Z-2538-2015Panoramic Rental Corp.
September 9, 2015LITHOTOMY PACK 10/CS Used by medical staff to perform surgical procedures and patient c…Z-2625-2015Customed, Inc
September 9, 2015NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional T…Z-2510-2015Halyard Health, Inc
September 9, 2015Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CAD-1338-2015South Coast Specialty Compounding, Inc.
September 9, 2015TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedure…Z-2565-2015Customed, Inc
September 9, 2015EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical proc…Z-2634-2015Customed, Inc
September 9, 2015SUCTION CATHETER KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedu…Z-2655-2015Customed, Inc
September 9, 2015Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CAD-1409-2015South Coast Specialty Compounding, Inc.
September 9, 2015UROLOGY PACK 5/CS Used by medical staff to perform surgical procedures and patient care…Z-2708-2015Customed, Inc
September 9, 2015(1) (2) 10/CS CUSTOMED Used by medical staff to perform surgical procedures and pati…Z-2635-2015Customed, Inc
September 9, 2015Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow…Z-2722-2015Transonic Systems Inc
September 9, 2015WESTBROOK'S CANNERY HOT DILL PICKLES, Net WT. 16 oz (453.592g) glass jars, Ingredients: W…F-3084-2015Westbrook's Cannery
September 9, 2015LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures …Z-2688-2015Customed, Inc
September 9, 2015GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical proc…Z-2620-2015Customed, Inc
September 9, 2015Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow i…Z-2723-2015Transonic Systems Inc
September 9, 2015Doubletree Cookie Dough, item number 2603450, Contents: 106 pieces, Net Weight: approx.…F-2815-2015Christie Cookie Co Inc
September 9, 2015OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures a…Z-2602-2015Customed, Inc
September 9, 2015UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures a…Z-2689-2015Customed, Inc
September 9, 2015WESTBROOK'S CANNERY HORSERADISH DILL PICKLES, Net WT. 16 oz (453.592G) glass jars, Ingred…F-3082-2015Westbrook's Cannery
September 9, 2015Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: S…Z-2525-2015Covidien LLC
September 9, 2015WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedur…Z-2556-2015Customed, Inc
September 9, 2015Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect Syste…Z-2547-2015Covidien LLC
September 9, 2015PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical proced…Z-2578-2015Customed, Inc
September 9, 2015WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures an…Z-2584-2015Customed, Inc
September 9, 2015Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Pa…D-1415-2015South Coast Specialty Compounding, Inc.
September 9, 2015SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla T…Z-2540-2015Limacorporate S.p.A
September 9, 2015GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient …Z-2704-2015Customed, Inc
September 9, 2015Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1,…Z-2487-2015Pointe Scientific, Inc.

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