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High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Medical Devices·166 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
Medical Devices·906 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 91 mm Item # 195279
Medical Devices·82 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·25,840 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 79 mm Item # 195252
Medical Devices·99 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 67 mm Item # 195247
Medical Devices·74 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 83 mm Item # 195277
Medical Devices·180 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·486 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Diagnostic Devices·16,983 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
Medical Devices·1,282 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vit...
Diagnostic Devices·25,383 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 65 mm Item # 195246
Medical Devices·43 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 63mm Item # 195269
Medical Devices·322 affected·Aug 15, 2019
High RiskFDA
Bioseal Corporation
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XX...
Medical Devices·900 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
Medical Devices·1,210 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 69 mm Item # 195248
Medical Devices·123 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
Medical Devices·973 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 71mm Item # 195273
Medical Devices·454 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·6,790 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 65mm Item # 195270
Medical Devices·375 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 73mm Item # 195274
Medical Devices·327 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 79 mm Item # 195276
Medical Devices·319 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·143,164 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
Medical Devices·480 affected·Aug 15, 2019
High RiskFDA
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 71 mm Item # 195249
Medical Devices·0 affected·Aug 15, 2019
High RiskFDA
Pfizer Inc.
RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x ...
Oral Drugs·20,117 affected·Aug 14, 2019
High RiskFDA
Wom World Of Medicine Ag
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic a...
Diagnostic Devices·322 affected·Aug 14, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ ...
Diagnostic Devices·169 affected·Aug 14, 2019
High RiskFDA
Bard Peripheral Vascular Inc
Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommend...
Surgical Devices·286 affected·Aug 14, 2019
High RiskFDA
New Standard Device Inc
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Medical Devices·14 affected·Aug 14, 2019
High RiskFDA
Ethicon, Inc.
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Medical Devices·852 affected·Aug 13, 2019
High RiskFDA
Livanova Usa Inc
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual f...
Medical Devices·6 affected·Aug 13, 2019
High RiskFDA
Olive Bakery
Chestnut bread packages contain two bread pastries filled with white bean paste filling and topped with sesame seeds on the outside. Pro...
Dairy·3 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Green Bean bread topped with black sesame seeds, packaged together in a clear plastic bag with a fold down stick seal. No net weight or n...
Dairy·7 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Red/ Walnut bread packages contain two bread pastries filled with red bean paste filling coated with egg on the outside and topped with w...
Dairy·3 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Peanut Butter bread packages contain two bread pastries filled with peanut butter filling. They are packaged together in a clear plastic...
Dairy·2 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Cream bread packages contain two bread pastries filled with custard filling. They are packaged together in a clear plastic bag with a fo...
Dairy·7 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Mocha Cream bread packages contain two bread pastries and each filled with a coffee filling with almonds on the outside. No net weight or...
Dairy·4 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Bavarian bread packages contain two bread pastries filled with Bavarian cream filling. They are packaged together in a clear plastic bag...
Dairy·3 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Peanut Crunch bread packages contain two bread pastries with no filling and topped with a peanut butter crunch on the outside. They are ...
Dairy·5 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Sweet Potato bread packages contain two bread pastries filled with white bean paste filling topped with black sesame seeds and cinnamon. ...
Dairy·3 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
White Bean bread is filled with white bean paste filling and topped with black sesame seeds, two pieces are packaged together in a clear...
Dairy·7 affected·Aug 12, 2019
High RiskFDA
Olive Bakery
Red Bean bread package contains two bread pastries filled with red bean paste filling, packaged in a clear plastic bag with a fold down s...
Dairy·41 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX
Drugs·2 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.
Drugs·1 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx
Injectable Drugs·0 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx
Drugs·3 affected·Aug 12, 2019
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx
Drugs·11 affected·Aug 12, 2019