FDA recalls, May 2020: 126 published

72 different companies appear this month.

Risk classification: Class I: 14 · Class II: 99 · Class III: 13

Same month, other agencies:CPSC 18 recallsFSIS 16 recallsNHTSA 74 recalls

Recalls this month

DateProduct
May 20, 2020TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 …Z-1950-2020Cardiac Assist, Inc
May 20, 2020Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cart…D-1262-2020The Harvard Drug Group
May 20, 2020ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) M…D-1268-2020Glaxosmithkline Consumer Healthcare Holdings
May 20, 2020Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable…Z-2005-2020Genicon, Inc.
May 20, 2020Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cio…Z-1958-2020Siemens Medical Solutions USA, Inc
May 20, 2020BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV…Z-1969-2020BD SWITZERLAND SARL
May 20, 2020Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5…Z-1985-2020Covidien Llc
May 20, 2020Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00…Z-2003-2020Inpeco S.A.
May 20, 2020Hearts of Romaine. Product is fresh and packaged in 9 ounce (255g) plastic bags.F-0944-2020Dole Fresh Vegetables Inc
May 20, 2020Joseph's Gluten Free Original Wrap, 4 wraps, Net. Wt. 5.6 oz., UPC Code: 074117-003612F-0939-2020Middle East Bakery, Inc.
May 20, 2020Dole "Classic Kit Light Cesar" fresh salad mix. Salad and topping Net Wt.7.7 OZ (218g), D…F-0943-2020Dole Fresh Vegetables Inc
May 20, 2020Common Market 1 % Milk (1/2 Gallon)F-0942-2020Natural Dairy Products
May 20, 2020Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium,…Z-1991-2020Covidien Llc
May 20, 2020ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Mark…D-1267-2020Glaxosmithkline Consumer Healthcare Holdings
May 20, 2020BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV…Z-1967-2020BD SWITZERLAND SARL
May 13, 2020Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 97355…Z-1905-2020Medtronic Navigation, Inc.
May 13, 2020Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872F-0950-2020Glaxosmithkline Consumer Healthcare Holdings
May 13, 2020Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx …D-1260-2020Teva Pharmaceuticals USA
May 13, 2020Simply Nature Organic Red Split Lentils, 16 oz bag, UPC 041498299507F-0932-2020Aldi Inc
May 13, 2020Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL)…D-1259-2020Sandoz, Inc
May 13, 2020REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infus…Z-1916-2020ICU Medical, Inc.
May 13, 2020Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202…Z-1888-2020Inpeco S.A.
May 13, 2020Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 oz./ 32 g pouch, Multi-layer K…F-0938-2020Jason Pharmaceuticals, Inc. t/a Medifast
May 13, 2020HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M002021758…Z-1871-2020Maquet Cardiovascular, LLC
May 13, 202016", 14", 13", 12", 10", 5" Hand Stretched Wheat Flour Tortillas, packaged in quantities …F-0935-2020La Sonorense, Inc.
May 13, 2020REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotatin…Z-1917-2020ICU Medical, Inc.
May 13, 202014", 10" Hand Stretched Whole Wheat Flour Tortillas, packaged in quantities of 1-2 dozen …F-0936-2020La Sonorense, Inc.
May 13, 2020HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M002021758…Z-1874-2020Maquet Cardiovascular, LLC
May 13, 2020daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 008868741…Z-1891-2020Intuitive Surgical, Inc.
May 13, 2020HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M002021759…Z-1882-2020Maquet Cardiovascular, LLC
May 13, 2020HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M002021759…Z-1876-2020Maquet Cardiovascular, LLC
May 13, 2020Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intende…Z-1838-2020Ivoclar Vivadent AG
May 13, 2020HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00…Z-1865-2020Maquet Cardiovascular, LLC
May 13, 2020Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydro…Z-1907-2020Gentell, Inc
May 13, 2020Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected …Z-1854-2020Nobel Biocare Usa Llc
May 13, 2020Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311Z-1922-2020Philips North America, LLC
May 13, 2020NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UD…Z-1851-2020Nobel Biocare Usa Llc
May 13, 2020HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M002021758…Z-1875-2020Maquet Cardiovascular, LLC
May 13, 2020TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE; Assorted dried fruits; NET WT 17.63 oz (500g) …F-0937-2020Royal International Trading Inc.
May 13, 2020Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connect…Z-1853-2020Nobel Biocare Usa Llc
May 13, 2020Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intend…Z-1840-2020Ivoclar Vivadent AG
May 13, 2020Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.Z-1903-2020Ortho Development Corporation
May 13, 202012", 10" Pressed Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. …F-0934-2020La Sonorense, Inc.
May 13, 2020Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; …Z-1846-2020Applied Medical Resources Corp
May 13, 2020Simply Nature Organic Green Lentils, 16 oz bag, UPC 041498299514F-0931-2020Aldi Inc
May 13, 2020Benefiber Prebiotic Fiber Supplement, packaged in the following ways 1) Net Wt. 500 g (17…F-0951-2020Glaxosmithkline Consumer Healthcare Holdings
May 13, 2020The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-00…Z-1927-2020ICU Medical, Inc.
May 13, 2020Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884…Z-1921-2020Philips North America, LLC
May 13, 2020Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product C…Z-1861-2020Maquet Cardiovascular, LLC
May 13, 2020HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175…Z-1869-2020Maquet Cardiovascular, LLC

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