FDA recalls, December 2020: 207 published

101 different companies appear this month.

Risk classification: Class I: 37 · Class II: 151 · Class III: 19

Same month, other agencies:CPSC 28 recallsFSIS 6 recallsNHTSA 79 recalls

Recalls this month

DateProduct
December 30, 2020Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body,…Z-0695-2021GE Healthcare, LLC
December 30, 2020IceSphere" 1.5 CX 90¿ Cryoablation NeedleZ-0664-2021Boston Scientific Corporation
December 30, 2020APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product …Z-0718-2021B Braun Medical, Inc.
December 30, 202042 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin S…Z-0699-2021ICU Medical, Inc.
December 30, 2020Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 m…Z-0706-2021ICU Medical, Inc.
December 30, 2020Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnosti…Z-0722-2021Siemens Healthcare Diagnostics, Inc.
December 30, 2020CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ (396g) Canyon Bakehouse, LLC…F-0182-2021Flowers Foods (Corporate Offices)
December 30, 2020Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for an…D-0170-2021Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
December 30, 2020IceSphere" 1.5 Cryoablation NeedleZ-0674-2021Boston Scientific Corporation
December 30, 2020Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Fle…Z-0608-2021Cook Inc.
December 30, 2020STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction…Z-0641-2021GA HEALTH COMPANY LIMITED
December 30, 2020Organic fresh cut basil packaged in plastic clamshell containers The Fresh Market Orga…F-0186-2021Shenandoah Growers, Inc.
December 30, 2020CACAO MARKET MARIE BELLE NEW YORK; Dark Chocolate Pearls; Ingredients: Cocoa bean, sugar,…F-0181-2021Maribel's Sweets, Inc.
December 30, 2020Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Fle…Z-0596-2021Cook Inc.
December 30, 2020IceSeed" 1.5 Cryoablation NeedleZ-0676-2021Boston Scientific Corporation
December 30, 2020Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Prod…Z-0696-2021Zimmer Biomet, Inc.
December 30, 2020Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Fle…Z-0599-2021Cook Inc.
December 30, 2020Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Fle…Z-0591-2021Cook Inc.
December 30, 2020Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the tr…Z-0724-2021Integra LifeSciences Corp.
December 30, 2020Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Fle…Z-0606-2021Cook Inc.
December 30, 2020Five IceSphere" Prostate Cryoablation KitZ-0689-2021Boston Scientific Corporation
December 30, 2020IceSeed" 1.5 MRI Cryoablation NeedleZ-0681-2021Boston Scientific Corporation
December 30, 2020IceRod" 1.5 CX 90¿ Cryoablation Needle¿Z-0663-2021Boston Scientific Corporation
December 30, 2020IceSeed" 1.5 90¿ Cryoablation NeedleZ-0675-2021Boston Scientific Corporation
December 30, 2020CANYON BAKEHOUSE GLUTEN MOUNTAIN WHITE BREAD NET WT. 18oz (1lb 2oz) 510g Canyon Bakehouse…F-0183-2021Flowers Foods (Corporate Offices)
December 30, 2020Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz …D-0174-2021Morton Grove Pharmaceuticals, Inc.
December 30, 2020Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for us…Z-0723-2021Biomet, Inc.
December 30, 2020ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393…Z-0648-2021GA HEALTH COMPANY LIMITED
December 30, 2020Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8F-0184-2021George DeLallo Co. Inc. New Stanton Warehouse and Production
December 30, 2020IceSphere" 1.5 S 90¿ Cryoablation NeedleZ-0672-2021Boston Scientific Corporation
December 30, 2020IcePearl" 2.1 CX Cryoablation NeedleZ-0661-2021Boston Scientific Corporation
December 30, 2020Presidents Choice Coleslaw 14 oz. plastic bag UPC:0-6038322267-3F-0188-2021Dole Fresh Vegetables Inc
December 30, 2020Organic Basil,15 bags, Net. Wt.15Lbs case.F-0185-2021Vallarta Organics LLC
December 30, 2020IcePearl" 2.1 CX 90¿ Cryoablation NeedleZ-0660-2021Boston Scientific Corporation
December 30, 2020Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple…Z-0654-2021Nova Ortho-Med Inc
December 30, 2020Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-r…Z-0694-2021GE Healthcare, LLC
December 30, 2020Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL …D-0172-2021Fresenius Kabi USA, LLC
December 30, 2020Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD,…Z-0655-2021Hardy Diagnostics
December 30, 2020MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial a…Z-0720-2021Beckman Coulter Inc.
December 30, 202030" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Fi…Z-0705-2021ICU Medical, Inc.
December 30, 2020Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container,…D-0171-2021SCA Pharmaceuticals, Inc.
December 30, 2020True Goodness by Meijer Organic Green Peas Frozen 10 Oz plastic bag UPC 7-08820-73708-2, …F-0187-2021Meijer Distribution
December 30, 2020Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Fle…Z-0598-2021Cook Inc.
December 30, 202026 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795Z-0711-2021ICU Medical, Inc.
December 30, 202030" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/…Z-0703-2021ICU Medical, Inc.
December 30, 2020Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Ki…Z-0645-2021GA HEALTH COMPANY LIMITED
December 30, 2020IceRod" 1.5 i-Thaw" Cryoablation NeedleZ-0665-2021Boston Scientific Corporation
December 23, 2020Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit…D-0145-2021Zydus Pharmaceuticals (USA) Inc
December 23, 2020THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indian…D-0133-2021Advanced Nutriceuticals, LLC
December 23, 2020Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product …Z-0629-2021Biomet, Inc.

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