FDA recalls, July 2018: 158 published

64 different companies appear this month.

Risk classification: Class I: 44 · Class II: 104 · Class III: 10

Same month, other agencies:CPSC 12 recallsFSIS 6 recallsNHTSA 60 recalls

Recalls this month

DateProduct
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobot…D-0993-2018Gaia Ethnobotanical LLC
July 18, 2018VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real tim…Z-2384-2018Arrow International Inc
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethn…D-1011-2018Gaia Ethnobotanical LLC
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia…D-0998-2018Gaia Ethnobotanical LLC
July 18, 2018Black Bean Job's Tears Tea, 35.3 oz. (KG) package Ingredients: Non Dairy Creamer (corn…F-1616-2018Hee Chang Dairy & Food Co., LTD
July 18, 2018Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pa…D-0912-2018Wockhardt Limited
July 18, 2018Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx …D-1030-2018AuroMedics Pharma LLC
July 18, 2018Earthrise Natural Spirulina; Net Weight: 20.0 kg( 44.0 lbs); Double bag sealed - 1 bag pe…F-1620-2018Earthrise Nutritionals Llc
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnob…D-1001-2018Gaia Ethnobotanical LLC
July 18, 2018Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container …D-0913-2018Wockhardt Limited
July 18, 2018Green Tea Latte; 35.3 oz. (1 kg) packet Ingredients: White sugar, Instant Whole Milk P…F-1618-2018Hee Chang Dairy & Food Co., LTD
July 18, 2018Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantab…Z-2412-2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
July 18, 2018Blue Bell Ice Cream, Brand Homemade Vanilla Flavored, 3 FL OZ (88 mL), Cups, 24 per box, …F-1614-2018Blue Bell Creameries, L.P.
July 18, 2018Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product …Z-2392-2018Steris Corporation
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobot…D-1013-2018Gaia Ethnobotanical LLC
July 18, 2018Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a s…D-0915-2018AMERICAN HEALTH PACKAGING
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia …D-1009-2018Gaia Ethnobotanical LLC
July 18, 2018Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 1…D-0917-2018Medgyn Products, Inc.
July 18, 2018Sparkling ICE Cherry Limeade Naturally Flavored Sparking Water, packaged in a PET bottles…F-1622-2018Talking Rain Beverage Co Inc
July 18, 2018Brew Dr. Kombucha Clear Mind, item Code: FCG0002, 6 glass bottles per case, net volume: 3…F-1619-2018Brew Dr Kombucha, LLC
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotan…D-0995-2018Gaia Ethnobotanical LLC
July 18, 2018Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030SZ-2407-2018Stryker GmbH
July 18, 2018Black Bean Cereal Latte; 28.2 oz. package Ingredients: Non Dairy Creamer (corn syrup, v…F-1615-2018Hee Chang Dairy & Food Co., LTD
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Et…D-1016-2018Gaia Ethnobotanical LLC
July 18, 2018Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032SZ-2394-2018Stryker GmbH
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnob…D-1014-2018Gaia Ethnobotanical LLC
July 18, 2018Wish Bone House Italian Salad Dressing 15 oz.F-1655-2018Pinnacle Food Group, Llc
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethno…D-1015-2018Gaia Ethnobotanical LLC
July 18, 2018BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For us…Z-2378-2018Medline Industries, Inc.
July 18, 2018Del Monte 6 oz. Veg Tray w/dip; Del Monte 12 oz. Veg Tray w/dip contains baby carrots, br…F-1612-2018Del Monte Fresh Produce N.A., Inc. HQ
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobot…D-1008-2018Gaia Ethnobotanical LLC
July 18, 2018Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in…D-0925-2018Sanofi-Aventis U.S. LLC
July 18, 2018Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., …D-0916-2018Akorn, Inc.
July 18, 2018Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Produc…Z-2385-2018Arrow International Inc
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobot…D-0994-2018Gaia Ethnobotanical LLC
July 18, 2018Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are impl…Z-2415-2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnob…D-0997-2018Gaia Ethnobotanical LLC
July 18, 2018Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only…D-0978-2018Mylan Pharmaceuticals Inc.
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethno…D-0999-2018Gaia Ethnobotanical LLC
July 18, 2018Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230SZ-2399-2018Stryker GmbH
July 18, 2018Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concent…D-0918-2018SCA Pharmaceuticals
July 18, 2018BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usag…Z-2429-2018bioMerieux, Inc.
July 18, 2018Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatr…Z-2423-2018Anika Therapeutics, Inc.
July 11, 2018Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceutica…D-0901-2018SCA Pharmaceuticals, LLC
July 11, 2018Icelandic Provisions Vanilla Skyr cups, 5.3oz package, UPC: 854074006068F-1606-2018Icelandic Provisions Inc.
July 11, 2018Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-00…Z-2364-2018Zimmer Biomet, Inc.
July 11, 2018Cantaloupe, multiple product sizes and brands, see as follows: Caito Foods Disributio…F-1624-2018Caito Foods Service, Inc.
July 11, 2018Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Via…D-0890-2018Ingenus Pharmaceuticals Llc
July 11, 2018Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceutic…D-0904-2018SCA Pharmaceuticals, LLC
July 11, 2018Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754Z-2377-2018Medtronic Inc.

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