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High RiskFDA
Haemonetics Corporation
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagul...
Medical Devices·88 affected·Feb 19, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 ...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·1,644 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control m...
Diagnostic Devices·10 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·628 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·5,004 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·400 affected·Feb 18, 2020
High RiskFDA
Randox Laboratories Ltd.
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, i...
Diagnostic Devices·186 affected·Feb 18, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Syst...
Medical Devices·1,012 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·21,326 affected·Feb 18, 2020
High RiskFDA
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surge...
Medical Devices·2,632 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog...
Diagnostic Devices·3 affected·Feb 18, 2020
High RiskFDA
Microbiologics Inc
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Diagnostic Devices·183 affected·Feb 18, 2020
High RiskFDA
Beckman Coulter, Inc.
iChemVELOCITY Strips, Catalog 800-7212
Medical Devices·10,822 affected·Feb 17, 2020
High RiskFDA
Cj Foods Inc., A Division Of Cj America
Annie Chun's Japanese Style Teriyaki Noodle Bowl with Cooked Hokkien Noodles - Sweet & Tangy sauce with Bok choy and carrots. Noodles ar...
Beverages·33,900 affected·Feb 14, 2020
High RiskFDA
Icu Medical, Inc.
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619...
Cardiac Devices·123 affected·Feb 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: A...
Diagnostic Devices·1,452 affected·Feb 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 1...
Diagnostic Devices·1,452 affected·Feb 14, 2020
High RiskFDA
Pepper Source, Ltd.
Bourbon Flavored BBQ Sauce (12.8 oz Pack) 45 Packs/Case
Food·328 affected·Feb 13, 2020
High RiskFDA
Suja Life Llc
Suja Organic Ginger Bliss Fruit + Veggie Smoothie, 12 oz. UPC: 81861702236
Beverages·9,005 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
Domino Premium Pure Cane Medium Brown Sugar, 50 LB bag, UPC 049200009727, Lots 50044 (Best By Jan 23, 2022) & 50045 (Best By Jan 24, 2022)
Food·2,250 affected·Feb 13, 2020
High RiskFDA
Pepper Source, Ltd.
PS# 86293 Mississippi Mash BBQ Sauce 30 Packs/ 20.2 oz. Net WT 37.88 each Carton and PS# 86295 Mississippi Mash BBQ Sauce (20.2 oz. packs...
Food·3,411 affected·Feb 13, 2020
High RiskFDA
Pepper Source, Ltd.
PS# 79770 Smoky Honey BBQ Sauce packed in 275 gallons totes
Food·36,233 affected·Feb 13, 2020
High RiskFDA
Suja Life Llc
Suja Organic Tropical Dragon Fruit + Veggie Smoothie, 12 oz. UPC: 81861702238
Beverages·8,798 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
Domino Premium Pure Cane Golden Light Brown Sugar, 50 LB bag, UPC 049200009727, Lots 50041 (Best By Jan 20, 2022), 50042 (Best By Jan 21,...
Food·3,100 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
C&H Pure Cane Sugar Golden Brown, 32 oz (2 LB) plastic bag, UPC 015800090038, Lots 50042 (Best By Jan 21, 2022) & 50043 (Best By Jan 22, ...
Food·1,960 affected·Feb 13, 2020
High RiskFDA
Pepper Source, Ltd.
PS# 58021 Honey BBQ Sauce Sauce (AFP) packed in 9 - 275 gallon totes
Food·21,194 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
HY-VEE Pure Cane Light Brown Sugar, 32 oz (2 LB) plastic bag, UPC 075450055177, Lots 50043 (Best By Jan 22, 2022) & 50044 (Best By Jan 23...
Food·1,260 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
Great Value Light Brown Sugar, 32 oz (2 LB) plastic bag, UPC 078742372211, Lots 50043 (Best By Jan 22, 2022), 50044 (Best By Jan 23, 2022...
Food·3,360 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
SYSCO Classic Light Brown Cane Sugar, 25 LB bag, UPC 074865990301, Lots 50043 (Best By Jan 22, 2022) & 50045 (Best By Jan 24, 2022)
Food·2,215 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
SYSCO Classic Light Brown Cane Sugar, 32 oz (2 LB) plastic bag, UPC 074865755368, Lots 50042 (Best By Jan 21, 2022) & 50051 (Best By Jan ...
Food·1,752 affected·Feb 13, 2020
High RiskFDA
Suja Life Llc
Suja Organic Mango Mojito Fruit + Veggie Smoothie, 12 oz. UPC: 81861702240
Beverages·6,817 affected·Feb 13, 2020
High RiskFDA
Domino Foods Inc
Domino Premium Pure Cane Light Brown Sugar, 16 oz (1 LB) box, UPC 049200056752, Lots 50045 (Best By Jan 24, 2022) & 50046 (Best By Jan 25...
Food·1,700 affected·Feb 13, 2020
High RiskFDA
Insulet Corporation
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG...
Diabetes Devices·32,756 affected·Feb 13, 2020
High RiskFDA
Sunrise Medical (us) Llc
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A...
Medical Devices·1 affected·Feb 13, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diag...
Diagnostic Devices·5,666 affected·Feb 13, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Prod...
Diagnostic Devices·1,639 affected·Feb 13, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellic...
Diagnostic Devices·2,323 affected·Feb 13, 2020
High RiskFDA
Lanvin French Bakery, Llc
Deep-fried Donut (Banh Tieu) 3.2-ounce package in clear plastic bag, no UPC, no brand. Product is labeled in part, "BANH TIEU***Ingred...
Bakery & Grains·49 affected·Feb 12, 2020
High RiskFDA
Lotte Int'l America Corp.
Lotte Choco Pie Cocao, 12 pack, 11.85 oz. (336 g) UPC: 8 801062 475148 Distributed by Lotte International America, Los Angeles, CA P...
Food·613 affected·Feb 12, 2020
High RiskFDA
Lanvin French Bakery, Llc
Deep-fried Bread (Banh Gio Chao Quay) 6-ounce package in clear plastic bag, no UPC, no brand. Product is labeled in part, "BANH GIO C...
Bakery & Grains·26 affected·Feb 12, 2020
High RiskFDA
Lotte Int'l America Corp.
Lotte Choco Pie Banana, 12 pack, 11.85 oz. (336 g) UPC: 8 45502 06140 7 Distributed by Lotte International America, Los Angeles, CA ...
Food·560 affected·Feb 12, 2020
High RiskFDA
Lotte Int'l America Corp.
Lotte Choco Pie Original, 12 pack 11.85 oz. (336 g) UPC: 8 801062 160709 Distributed by Lotte International America, Los Angeles, CA ...
Food·80 affected·Feb 12, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltim...
Oral Drugs·6,294 affected·Feb 12, 2020
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correc...
Medical Implants·190 affected·Feb 12, 2020
High RiskFDA
Boston Scientific Corporation
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended ...
Medical Implants·4 affected·Feb 12, 2020
High RiskFDA
Microbiologics Inc
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845...
Medical Devices·49 affected·Feb 12, 2020
High RiskFDA
Csm Bakery Products
35 lb. pail VANILLA XTRA SMOOTH BUTTERCREME FROSTING, MDM # 10203023, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILL...
Dairy·10,080 affected·Feb 11, 2020