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High RiskFDA
Becton Dickinson & Company
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
Medical Devices·967,680 affected·Oct 14, 2019
High RiskFDA
Becton Dickinson & Company
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Medical Devices·1,632,000 affected·Oct 14, 2019
High RiskFDA
Mizuho Osi
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used ...
Medical Devices·174 affected·Oct 14, 2019
High RiskFDA
Relish Foods, Inc. Dba Gourmet Fusion Foods, Inc.
Trade Winds Premium Grade Yellowfin (Ahi) Tuna Ground Keep Frozen Net Weight 10 LBS. (4.54 KG) Product of Vietnam Specifically Packe...
Seafood·600 affected·Oct 11, 2019
High RiskFDA
Lifelines Neuro Company
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended...
Diagnostic Devices·8 affected·Oct 11, 2019
High RiskFDA
Implant Direct Sybron Manufacturing Llc
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Medical Implants·78 affected·Oct 11, 2019
High RiskFDA
Nucryo Vascular Inc.
The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the dis...
Surgical Devices·49 affected·Oct 11, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an au...
Diagnostic Devices·1,528 affected·Oct 11, 2019
High RiskFDA
Lifelines Neuro Company
ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is inte...
Diagnostic Devices·12 affected·Oct 11, 2019
High RiskFDA
Dollar General Corporation
Sweet Smiles brand Select Dark Chocolate with Orange Peel Bar in 3.5 oz. foil wrapper packaging.
Snacks & Candy·405,120 affected·Oct 10, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·290 affected·Oct 10, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·1,747 affected·Oct 10, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·3,905 affected·Oct 10, 2019
High RiskFDA
Innoveix Pharmaceuticals Inc
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Injectable Drugs·413 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 0043...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Connection Screw for NCB Plate, Item No. 0202266002
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 002347...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 3...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 4723570...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263...
Medical Implants·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical...
Medical Implants·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 0011810...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 4723580...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 0022400...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
LPS-MOB ART SURF IMPL D 9MM
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 002...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 ...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006...
Medical Implants·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Hologic, Inc
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a bu...
Diagnostic Devices·47 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800...
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Trilliant Surgical, Llc
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit fac...
Medical Implants·5 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 010029610...
Medical Implants·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Ingenus Pharmaceuticals Llc
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. ...
Injectable Drugs·16,485 affected·Oct 9, 2019
High RiskFDA
Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourc...
Injectable Drugs·162 affected·Oct 9, 2019
High RiskFDA
Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/...
Injectable Drugs·1,370 affected·Oct 9, 2019
High RiskFDA
Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL,...
Injectable Drugs·1,855 affected·Oct 9, 2019
High RiskFDA
Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Co...
Drugs·1,047 affected·Oct 9, 2019