FDA recalls, September 2018: 158 published

62 different companies appear this month.

Risk classification: Class I: 16 · Class II: 130 · Class III: 12

Same month, other agencies:CPSC 23 recallsFSIS 8 recallsNHTSA 99 recalls

Recalls this month

DateProduct
September 19, 2018Dewey's BAKERY Soft Baked TRIPLE CHOCOLATE BROWNIE COOKIES NET WT. 6 OZ paper bag Dewey's…F-1962-2018Dewey's Bakery, Inc dba Salem Baking Company
September 19, 2018Shredded green cabbageF-1979-2018Air Stream Corp.
September 19, 2018Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400Z-3144-2018Zimmer Biomet, Inc.
September 19, 2018Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, I…D-1202-2018Hellolife
September 19, 2018Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360Z-3092-2018Zimmer Biomet, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400Z-3138-2018Zimmer Biomet, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440Z-3053-2018Zimmer Biomet, Inc.
September 19, 2018Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Exp…Z-3035-2018SPS Sterilization, Inc
September 19, 2018Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280Z-3164-2018Zimmer Biomet, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360Z-3083-2018Zimmer Biomet, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460Z-3097-2018Zimmer Biomet, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360Z-3143-2018Zimmer Biomet, Inc.
September 19, 2018Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile…D-1184-2018Pfizer Inc.
September 19, 2018Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Cont…D-1189-2018SCA Pharmaceuticals, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340Z-3071-2018Zimmer Biomet, Inc.
September 19, 2018Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination…Z-2994-2018Diagnostica Stago, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460Z-3054-2018Zimmer Biomet, Inc.
September 19, 2018Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Phar…D-1186-2018Mylan Pharmaceuticals Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400Z-3085-2018Zimmer Biomet, Inc.
September 19, 2018Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300Z-3165-2018Zimmer Biomet, Inc.
September 12, 2018Sammy Salsa Happy Medium, packaged in 14 oz. plastic container, 6 units per case. UPC # …F-1949-2018Sammy Food Products LLC
September 12, 2018Delish Vegetable Garden Salad, 10.5 oz. UPC 49022542426F-1942-2018Caito Foods LLC.
September 12, 2018AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only…D-1174-2018Avkare Incorporated
September 12, 2018AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, …D-1175-2018Avkare Incorporated
September 12, 2018Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (…Z-2981-2018Alden Optical
September 12, 2018Sammy Salsa Roasted Cabo Verde, packaged in 14 oz. plastic container, 6 units per case. U…F-1952-2018Sammy Food Products LLC
September 12, 2018AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative…Z-1220-2018PerkinElmer Life and Analytical Sciences, Wallac, OY
September 12, 2018McDonalds Salad Ingredients, 9.25 lb, Salad Blend Romaine, Carrot & Spinach, Kale, Red Le…F-1948-2018Fresh Express Incorpated
September 12, 2018Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used f…Z-2965-2018Zimmer Biomet, Inc.
September 12, 2018Garden Highway Vegetable Garden Salad, 8 oz. UPC 826766009435F-1936-2018Caito Foods LLC.
September 12, 2018Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injec…Z-2961-2018Bayer Medical Care, Inc.
September 12, 2018GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system …Z-2987-2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
September 12, 2018Small Garden Salad, 9.3 oz. UPC 0081851402182F-1935-2018Caito Foods LLC.
September 12, 2018GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound …Z-2990-2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
September 12, 2018Vegetable Garden Salad, 8 oz. UPC 0081851223497F-1940-2018Caito Foods LLC.
September 12, 2018AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only…D-1176-2018Avkare Incorporated
September 12, 2018Sammy Salsa Smok'n Chipotle, packaged in 14 oz. plastic container, 6 units per case. UPC …F-1951-2018Sammy Food Products LLC
September 12, 2018Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkle…Z-2975-2018Quasar Bio-Tech, Inc.
September 12, 2018Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm …D-1183-2018Akorn, Inc.
September 12, 2018Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bo…F-1932-2018VIRTUS PHARMACEUTICALS LLC.
September 12, 2018VidiStar(TM) PACS & DICOM Viewer Software systemZ-2992-2018Hitachi Healthcare Americas Corp Informatics Division
September 12, 2018Garden Highway Mt. Olympus Greek Salad, 8 oz. UPC 0826766009374F-1934-2018Caito Foods LLC.
September 12, 2018Garden Salad with Homestyle Ranch Dressing, 11.5 oz. UPC 0826766141036F-1941-2018Caito Foods LLC.
September 5, 2018Red Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "How…F-1916-2018Howard Calcagno Farms
September 5, 2018Cilantro was shipped in card board boxes that are labeled with the firm name "Howard Calc…F-1914-2018Howard Calcagno Farms
September 5, 2018P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830Z-2949-2018DePuy Orthopaedics, Inc.
September 5, 2018Mint was shipped in card board boxes that are labeled with the firm name "Howard Calcagno…F-1928-2018Howard Calcagno Farms
September 5, 2018Lacinato Kale was shipped in card board boxes that are labeled with the firm name "Howard…F-1926-2018Howard Calcagno Farms
September 5, 2018Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Ha…D-1147-2018Pharmcore Inc.
September 5, 2018Romaine Lettuce was shipped in card board boxes that are labeled with the firm name "Howa…F-1917-2018Howard Calcagno Farms

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