FDA recalls, August 2016: 245 published

98 different companies appear this month.

Risk classification: Class I: 99 · Class II: 136 · Class III: 10

Same month, other agencies:CPSC 27 recallsFSIS 9 recallsNHTSA 71 recalls

Recalls this month

DateProduct
August 31, 2016Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomograp…Z-2653-2016Philips Medical Systems (Cleveland) Inc
August 31, 2016RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK…Z-2633-2016Medtronic Sofamor Danek USA Inc
August 31, 2016TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .Z-2635-2016Medtronic Sofamor Danek USA Inc
August 24, 2016VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 29…Z-2580-2016ORTHO-CLINICAL DIAGNOSTICS
August 24, 2016Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implantsZ-2418-2016Biomet 3i, LLC
August 24, 2016IOL Distal Extension Dental implantsZ-2475-2016Biomet 3i, LLC
August 24, 2016Certain Conical 17 degree Angled Abutment Dental implantsZ-2513-2016Biomet 3i, LLC
August 24, 2016Provide Protection Cap Dental implantsZ-2441-2016Biomet 3i, LLC
August 24, 2016Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental impl…Z-2419-2016Biomet 3i, LLC
August 24, 20161.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Produ…Z-2544-2016LeMaitre Vascular, Inc.
August 24, 2016Certain Micromini Flat Implant Cover Screw Dental implantsZ-2488-2016Biomet 3i, LLC
August 24, 2016Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, N…D-1458-2016Golden State Medical Supply Inc.
August 24, 2016Certain Bellatek Encode Healing Abutment Dental implantsZ-2512-2016Biomet 3i, LLC
August 24, 2016Sun Life Natural Sunflower Spread in clear plastic jar with brown plastic lid, Net Wt. 12…F-1927-2016Nu Life Market LLC
August 24, 2016Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06)…D-1460-2016Zydus Pharmaceuticals USA Inc
August 24, 2016Gold Slotted Screw Dental implantsZ-2466-2016Biomet 3i, LLC
August 24, 2016Bulk flour bland breader packaged into 15, 30, and 50 lb bags or boxes.F-1922-2016Newly Weds Foods Inc
August 24, 2016Locator Replacement Males 4pk Dental implantsZ-2433-2016Biomet 3i, LLC
August 24, 2016Conical EP Healing Cap Dental implantsZ-2452-2016Biomet 3i, LLC
August 24, 2016Seared Steak with Spring Veggie Succotash and Mint-Chive PestoF-1934-2016HELLOFRESH
August 24, 2016Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exha…Z-2550-2016Resmed Corporation
August 24, 20163/8" White Onion Strip-FRESH, item number 105196, bulk totes, net wt. 1200 lbs.F-1944-2016Oregon Potato Company
August 24, 2016Certain Preformance 15 degrees Pre-Angled Post Dental implantsZ-2491-2016Biomet 3i, LLC
August 24, 2016Golden Dipt¿ Jalape¿o Breader is in a white 10 pound bag with the UPC number 763089721548…F-1916-2016Kerry, Inc
August 24, 2016AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. …Z-2529-2016Ab Sciex
August 24, 2016Sun Life Natural Sunflower Spread with Maple in clear plastic jar with brown plastic lid,…F-1928-2016Nu Life Market LLC
August 24, 2016Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx O…D-1459-2016Golden State Medical Supply Inc.
August 24, 2016Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Pat…D-1457-2016Actavis Inc
August 24, 2016Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implantsZ-2509-2016Biomet 3i, LLC
August 24, 2016Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental impla…Z-2417-2016Biomet 3i, LLC
August 24, 2016Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use steri…Z-2530-2016Danville Materials, Inc.
August 24, 2016Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258…Z-2557-2016Medtronic
August 24, 2016Conical EP Twist Lock TM Coping Dental implantsZ-2455-2016Biomet 3i, LLC
August 24, 2016Conical Abutment Gold Standard ZR TM Dental implantsZ-2507-2016Biomet 3i, LLC
August 24, 2016Nir's Lamb-Stuffed Zucchini with Spiced Lentil StewF-1935-2016HELLOFRESH
August 24, 2016Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: …Z-2533-2016Baxter Healthcare Corp.
August 24, 2016Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The …Z-2555-2016Medtronic
August 24, 2016LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implantsZ-2422-2016Biomet 3i, LLC
August 24, 2016Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Val…Z-2574-2016Medtronic
August 24, 2016IOL Healing Cap Dental implantsZ-2476-2016Biomet 3i, LLC
August 24, 2016Certain Twist Lock TM Coping Dental implantsZ-2501-2016Biomet 3i, LLC
August 24, 2016Gold-Tite Square Uniscrew Item: UNISG Dental implantsZ-2421-2016Biomet 3i, LLC
August 24, 2016Sun Life Natural Sunflower Kernel Paste, Net Wt. 40 lbs (18.18 kg) buckets and 450 lbs. (…F-1925-2016Nu Life Market LLC
August 24, 2016Locator Light Retention Replacement Males 4pk Dental implantsZ-2430-2016Biomet 3i, LLC
August 24, 2016Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying,…Z-2549-2016Mindray DS USA, Inc. dba Mindray North America
August 24, 2016Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Va…Z-2575-2016Medtronic
August 24, 2016Certain Conical 25 degree Angled Abutment Dental implantsZ-2514-2016Biomet 3i, LLC
August 24, 2016Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implantsZ-2413-2016Biomet 3i, LLC
August 24, 2016Certain Standard Abutment Dental implantsZ-2495-2016Biomet 3i, LLC
August 24, 20161.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The …Z-2543-2016LeMaitre Vascular, Inc.

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