FDA recalls, August 2017: 597 published

108 different companies appear this month.

Risk classification: Class I: 69 · Class II: 476 · Class III: 52

Recalls this month

DateProduct
August 16, 2017PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys…Z-2879-2017Valorem Surgical LLC
August 16, 2017Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1…Z-2847-2017International Medsurg Connection, Inc.
August 16, 2017PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation Sys…Z-3011-201Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation …Z-2977-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS 30mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem…Z-2882-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System…Z-2993-2017Valorem Surgical LLC
August 16, 2017PALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation Syst…Z-2972-2017Valorem Surgical LLC
August 9, 2017Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Preci…D-1037-2017Precision Dose Inc.
August 9, 2017Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Wo…Z-2779-2017Myelotec, Inc.
August 9, 2017NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINI…Z-2798-2017Sorin Group USA, Inc.
August 9, 2017SAMI'S BAKERY, Date Almond Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery In…F-2955-2017Sami's Pita Bakery, Inc.
August 9, 2017MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for…Z-2867-2017Sentinel CH SPA
August 9, 2017SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx…Z-2793-2017Sorin Group USA, Inc.
August 9, 2017Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10…D-1048-2017Hospira a Pfizer Company
August 9, 2017Natures Promise Cranberry Trail Mix 12oz.F-3340-2017United Natural Trading Inc. dba Woodstock Farms
August 9, 2017Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0…D-1049-2017Hospira a Pfizer Company
August 9, 2017Woodstock Organic Kumbaya Mix 10oz.F-3342-2017United Natural Trading Inc. dba Woodstock Farms
August 9, 2017Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x…D-1039-2017Teva Pharmaceuticals USA
August 9, 2017ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006Z-2781-2017Greatbatch Medical
August 9, 2017Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate…D-1050-2017Bayer HealthCare Pharmaceuticals, Inc.
August 9, 2017InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, …Z-2803-2017Quidel Corporation
August 9, 2017Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Man…D-1035-2017Apace KY LLC
August 9, 2017Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and …Z-2782-2017Greatbatch Medical
August 9, 2017Wholesome Pantry Organic Trail Mix 8oz.F-3347-2017United Natural Trading Inc. dba Woodstock Farms
August 9, 2017Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvabl…F-3348-2017Professional Complementary Health Formulas, LLC
August 9, 2017Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufa…D-1041-2017Zydus Pharmaceuticals USA Inc
August 9, 2017Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample proce…Z-2864-2017Hologic, Inc
August 9, 2017Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, …D-1051-2017Bayer HealthCare Pharmaceuticals, Inc.
August 9, 2017Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-0…D-1043-2017Zydus Pharmaceuticals USA Inc
August 9, 2017Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, lab…D-1054-2017Vi-Jon, Inc.
August 9, 2017Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01…D-1042-2017Zydus Pharmaceuticals USA Inc
August 9, 2017SAMI'S BAKERY, Walnut Chocolate Chip Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita…F-2956-2017Sami's Pita Bakery, Inc.
August 9, 2017SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EAZ-2794-2017Sorin Group USA, Inc.
August 9, 2017Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular…Z-2780-2017Ortho Solutions Inc
August 9, 2017SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx O…Z-2785-2017Sorin Group USA, Inc.
August 9, 2017Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90…D-1038-2017Dr. Reddy's Laboratories, Inc.
August 9, 2017IQF White Rice ES CA, Cardboard Tote, product #4621686100.F-3336-2017General Mills, Inc
August 9, 2017Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Ca…Z-2799-2017Stryker Neurovascular
August 9, 2017GE Inspection Technologies Blade|line Industrial Cabinet X-ray systemZ-2777-2017GE Inspection Technologies, LP
August 9, 2017SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Onl…Z-2789-2017Sorin Group USA, Inc.
August 9, 2017Whole Foods Market Thai Shrimp Salad, Net Wt. 14 oz.. packaged in a clear clamshell con…F-3349-2017Cafe Spice GCT DBA Zaika Flavors of India Inc.
August 9, 20178.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/m…D-1047-2017Hospira a Pfizer Company
August 9, 2017Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS …Z-2800-2017Stryker Neurovascular
August 9, 2017Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated O…D-1057-2017PD-Rx Pharmaceuticals, Inc.
August 9, 2017Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Man…D-1036-2017Apace KY LLC
August 9, 2017Steamers in 5 Clams in Butter & Garlic Sauce, Goose Point brand. Product is packaged in …F-2953-2017Nisbet Oyster Co Inc
August 9, 2017ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of …Z-2868-2017Zimmer Biomet, Inc.
August 9, 2017SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 0440426…Z-2788-2017Sorin Group USA, Inc.
August 9, 2017SAMI'S BAKERY, BAKLAVA WALNUT, Net Weight. 4oz (112g)., Refer questions or comments to: S…F-2958-2017Sami's Pita Bakery, Inc.
August 9, 2017Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS …Z-2801-2017Stryker Neurovascular

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