FDA recalls, June 2018: 106 published

56 different companies appear this month.

Risk classification: Class I: 13 · Class II: 84 · Class III: 9

Same month, other agencies:CPSC 15 recallsFSIS 16 recallsNHTSA 99 recalls

Recalls this month

DateProduct
June 20, 2018The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Syste…Z-2167-2018BioMerieux SA
June 20, 2018MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT.…Z-2155-2018Sun Med, LLC
June 20, 2018EconoMax Vanilla, 4 quarts and 56 ouncesF-1551-2018H-E-B GROCERY COMPANY LP DBA HEB
June 20, 2018cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully auto…Z-2136-2018Roche Diagnostics Corporation
June 20, 2018Hill Country Fare Cookies and Cream 56 ouncesF-1553-2018H-E-B GROCERY COMPANY LP DBA HEB
June 20, 2018RS 5F DL BIOFLO PASV, Catalog Number 60M132324Z-2205-2018Angiodynamics Inc. (Navilyst Medical Inc.)
June 20, 2018Coffee Toffee - 4 oz. packages. UPC 6 55974 89001 2. The label is read in parts: "***I…F-1578-2018Yukon Jackson
June 20, 2018Proteus ONE and Proteus PlusZ-2139-2018Ion Beam Applications S.A.
June 20, 2018Snak Club Tropical Trail Mix: 16 oz. plastic pouch: Ingredients: Raisins, Peanuts, Pi…F-1543-2018New Century Snacks LLC
June 20, 2018Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber P…D-0872-2018MBi Distributing Inc. dba MBi Nutraceuticals
June 20, 2018Milk Chocolate Covered Fudge Bites, 3.75oz, PET Pouch, 12 packages per caseF-1549-2018Morley Candy Makers, Inc.
June 20, 2018Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydro…D-0842-2018RIJ Pharmaceutical LLC
June 13, 2018L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a…Z-2130-2018Orthofix, Inc
June 13, 2018Melanie Mini Cookies with Caramel Flavor in a 17.6 oz (500g) clear plastic package with U…F-1595-2018Desly International Corp.
June 13, 2018ST-AIA PACK Cort; Part Number: 025287 Assay, MetabolicZ-2094-2018Tosoh Bioscience Inc
June 13, 2018Melanie Liubitelskie Cookies in a 17.6 oz (500g) clear plastic package with UPC 477004901…F-1594-2018Desly International Corp.
June 13, 2018Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW wi…Z-2101-2018GE Healthcare
June 13, 2018ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive HormoneZ-2087-2018Tosoh Bioscience Inc
June 13, 2018Baskin Robbins Mint Chocolate ChipF-1545-2018Dean Foods, Inc.
June 13, 2018TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 1…Z-2063-2018Orthofix Srl
June 13, 2018Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or…Z-2046-2018Draeger Medical Systems, Inc.
June 13, 2018RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of …Z-2059-2018Randox Laboratories
June 13, 2018Broccoli cuts, All Natural, No Preservatives, Net Wt 16 OZ; Distributed by Foodhold USA, …F-1535-2018Ahold USA
June 13, 2018Code - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6…F-1534-2018The C.F. Sauer Company
June 13, 2018Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged …D-0865-2018Pharmaceutical Associates Inc
June 13, 2018XZB Grilled Crispy Shrimp (20g*20 and 16g*24) UPC Code (16g) 6923006800082F-1538-2018KUIYI INTERNATIONAL INC.
June 13, 2018Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOF…Z-2116-2018Orthofix, Inc
June 13, 2018Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, …Z-2113-2018Baxter Healthcare Corporation
June 13, 2018Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd…D-0876-2018Jubilant Cadista Pharmaceuticals, Inc.
June 13, 20183910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Di…Z-2057-2018Stryker Corporation
June 13, 2018ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive HormoneZ-2093-2018Tosoh Bioscience Inc
June 13, 2018Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (…Z-2135-2018Orthofix, Inc
June 13, 2018Ethanol Extraction 190 Proof Non-Denatured Grain Alcohol, Multiple sizes: 8 oz, 16 oz, 3…F-1536-2018Lake Michigan Distilling Co LLC
June 13, 2018Priano Rosso Pesto Sauce, 6.7oz glass jarF-1548-2018BLM Products U. Vertriebsges
June 6, 20184Fr. Catheter Clamp with Fastener; Product Code: CC-00004Z-2006-2018Arrow International Inc
June 6, 2018Radial Arterial Access Kit; Product Code: ASK-04001-BID2Z-1968-2018Arrow International Inc
June 6, 2018Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, U…Z-1955-2018Dynarex Corporation
June 6, 2018Liberty Snacks NUTS ALMOND RAISIN Mix Net Wt. 1.6 oz (#g) DISTRIBUTED BY Liberty Candy & …F-1501-2018Ohio Hickory Harvest Brand Products Inc.
June 6, 2018Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Sa…Z-1977-2018Arrow International Inc
June 6, 20187K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. …D-0880-2018Shoreside Enterprises Inc.
June 6, 2018Maximal Barrier Drape; Product Code: ASK-04000-HMCZ-1967-2018Arrow International Inc
June 6, 20188Fr. Catheter Clamp with Fastener; Product Code: CC-00008Z-2009-2018Arrow International Inc
June 6, 2018Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS…Z-2003-2018Arrow International Inc
June 6, 2018Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument…Z-1942-2018Olsen Medical
June 6, 2018VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJZ-2026-2018Arrow International Inc
June 6, 2018nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to…Z-2045-2018NordicNeuroLab AS
June 6, 2018POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Di…D-0879-2018Shoreside Enterprises Inc.
June 6, 2018Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Ki…Z-1988-2018Arrow International Inc
June 6, 2018Epidural Needle; Product Codes: AN-05501 and AN-05505Z-1961-2018Arrow International Inc
June 6, 2018Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052Z-2021-2018Arrow International Inc

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