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High RiskFDA
Heartware, Inc.
HeartWare Model 1100
Cardiac Devices·45 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Cardiac Devices·6 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare Model 1101
Cardiac Devices·82 affected·Nov 29, 2022
High RiskFDA
Acumed Llc
Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm ...
Medical Devices·1,681,860 affected·Nov 29, 2022
High RiskFDA
Biomet, Inc.
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, i...
Medical Devices·2 affected·Nov 29, 2022
High RiskFDA
Acumed Llc
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak...
Medical Devices·7,498 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1103
Cardiac Devices·5,704 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104
Cardiac Devices·10,320 affected·Nov 29, 2022
High RiskFDA
Rocky Mountain Pies, Llc
Red Button Vintage Creamery French Silk Pie, Net Wt. 31.88 oz. (904g), in a clear plastic dome and black plastic base, UPC 0 41172 81290 ...
Food·1,116 affected·Nov 28, 2022
High RiskFDA
B. Braun Medical, Inc.
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 ...
Injectable Drugs·756 affected·Nov 25, 2022
High RiskFDA
Kerry Inc
KERRY PRE IDQ 61-03 TND 50# 227262 300-121584, NET WEIGHT: 50 LB (22.68KG) INGREDIENTS: Bleached Enriched Wheat Flour***Bread Crumbs***Co...
Bakery & Grains·24 affected·Nov 23, 2022
High RiskFDA
Heritage Pharmaceuticals Inc
Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 2...
Oral Drugs·13,805 affected·Nov 23, 2022
High RiskFDA
Baxter Healthcare Corporation
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Medical Devices·14,053,824 affected·Nov 23, 2022
High RiskFDA
Baxter Healthcare Corporation
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Medical Devices·6,338,280 affected·Nov 23, 2022
High RiskFDA
Covidien, Llc
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Surgical Devices·21 affected·Nov 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max (VE10, VF10, VF11)
Medical Devices·704 affected·Nov 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos dRF Max (VE10, VF10, VF11)
Medical Devices·704 affected·Nov 23, 2022
High RiskFDA
Xo Marshmallow, Llc
XO Marshmallow Limited Edition: Banana Puddin' OMG (Ooey Marshmallow Goodness), 12oz. marshmallow fluff, 4 12oz. retail units per case
Food·526 affected·Nov 22, 2022
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per...
Injectable Drugs·40,025 affected·Nov 22, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 P...
Injectable Drugs·4,097 affected·Nov 22, 2022
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 ...
Injectable Drugs·31,600 affected·Nov 22, 2022
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg ...
Injectable Drugs·40,375 affected·Nov 22, 2022
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immu...
Diagnostic Devices·115 affected·Nov 22, 2022
High RiskFDA
Randox Laboratories Ltd.
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems ...
Diagnostic Devices·146 affected·Nov 22, 2022
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Medical Devices·3,896 affected·Nov 22, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Sourdough Biscuits UPC 44216-26512 packaged in metal tin with clear plastic nonflexible lid
Food·114 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Sweet Potato Biscuits 44216-26522 packaged in metal tin with clear plastic nonflexible lid
Food·158 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Everything Biscuits UPC 44216-26532 packaged in metal tin with clear plastic nonflexible lid
Food·3 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Cinnabiscuits UPC 44216-26552 packaged in metal tin with clear plastic nonflexible lid
Food·202 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Maple Pecan Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
Food·18 affected·Nov 21, 2022
High RiskFDA
Hippos And Hashbrowns
Take & Bake Blueberry Biscuits no UPC packaged in metal tin with clear plastic nonflexible lid
Produce·18 affected·Nov 21, 2022
High RiskFDA
Becton Dickinson & Co.
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Medical Devices·9,600 affected·Nov 21, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Surgical Devices·148 affected·Nov 21, 2022
High RiskFDA
Medtronic Minimed
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Medical Devices·3,235 affected·Nov 21, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Medical Devices·36 affected·Nov 18, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Medical Devices·31,300 affected·Nov 18, 2022
High RiskFDA
Devilbiss Healthcare Llc
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Respiratory Devices·1,004,315 affected·Nov 18, 2022
High RiskFDA
Amys Kitchen Inc
Amy's Kitchen Gluten Free Bean and Cheese Burrito 5.5 oz. individually wrapped plastic packages - 12 units per case UPC - 042272-00353-2 ...
Dairy·5,134 affected·Nov 17, 2022
High RiskFDA
Phil's Power Pancake
Phil's Power Pancakes 5 oz. individually wrapped units 5 varieties, including (Chocolate Hempseed, Cranberry, Raspberry, Mango, and Date)...
Bakery & Grains·500 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. AC...
Medical Devices·6,420 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Medical Devices·20 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Medical Devices·36 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NEC...
Medical Devices·9,079 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e....
Medical Devices·11,886 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEAR...
Medical Implants·12,964 affected·Nov 17, 2022
High RiskFDA
Ottlite Technologies, Inc.
OttLite Rechargeable UVC Disinfecting Wand
Medical Devices·7,376 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOT...
Medical Devices·1,212 affected·Nov 17, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY C...
Medical Devices·42,593 affected·Nov 17, 2022