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High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body b...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body ...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Sargento Foods, Inc.
Sargento IQF Goat Cheese with Tomatoes and Kale. Product 10001148 and 4610034611 1/28 lb., Net Wt 28.000 lbs. Keep Frozen. Manufacture...
Dairy·857 affected·Oct 17, 2018
High RiskFDA
Sargento Foods, Inc.
Sargento IQF Veggie Burger. Product 10001725 6/4 lb., and Product 4610035085 6/4lb. Keep Frozen. Manufactured by Sargento Foods, Inc.,...
Frozen Food·99 affected·Oct 17, 2018
High RiskFDA
The Wornick Company
Chef Sensations Fire Roasted 1/2" diced onion/pepper blend Net Wt 20 lbs
Produce·178,170 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-15...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-1...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-1...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Qualgen, Llc
Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-3...
Drugs·0 affected·Oct 17, 2018
High RiskFDA
Leoni Fiber Optics Gmbh
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope pack...
Surgical Devices·0 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·21,071 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with ren...
Medical Devices·59,100 affected·Oct 17, 2018
High RiskFDA
Leoni Fiber Optics Gmbh
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Pack...
Surgical Devices·0 affected·Oct 17, 2018
High RiskFDA
Leoni Fiber Optics Gmbh
Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging....
Surgical Devices·0 affected·Oct 17, 2018
High RiskFDA
Leoni Fiber Optics Gmbh
Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. ...
Surgical Devices·0 affected·Oct 17, 2018
High RiskFDA
Richard Wolf Gmbh
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscope...
Medical Implants·873 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·15,880 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal ...
Medical Devices·186,476 affected·Oct 17, 2018
High RiskFDA
Leoni Fiber Optics Gmbh
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. ...
Surgical Devices·0 affected·Oct 17, 2018
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with re...
Medical Devices·7,275 affected·Oct 17, 2018
High RiskFDA
Buddy's Kitchen Inc
Mushroom & Thyme Flatbread Pizza, Item 70610. Net Weight 7.65 lbs. 48-2.55 oz. portions. Keep Frozen. For institutional use only. Bu...
Bakery & Grains·4,481 affected·Oct 16, 2018
High RiskFDA
Buddy's Kitchen Inc
Stir Fry Wrap with Rice, Broccoli & Peppers, Item 70668. Net Weight 17.50 lbs. 56 - 5.00 oz. portions. Keep Frozen. For institutional...
Frozen Food·1,449 affected·Oct 16, 2018
High RiskFDA
Bakkavor Foods Usa, Inc.
Trader Joe's Tomato & Basil Hummus Dip, 7 oz. plastic container; Perishable, Keep Refrigerated. SKU 29153
Produce·104,616 affected·Oct 16, 2018
High RiskFDA
Buddy's Kitchen Inc
Philly Steak Sandwich, Item 06433. Net Weight 17.50 lbs. 56 - 5.00 oz. portions. Keep Frozen. For institutional use only. Buddy's Ki...
Frozen Food·12,179 affected·Oct 16, 2018
High RiskFDA
Lone Star Bakery, Inc
Veggie Pie packaged in a paper carton, Net Wt 6 OZ, Keep Frozen
Frozen Food·450 affected·Oct 16, 2018
High RiskFDA
Lone Star Bakery, Inc
Spinach and Mushroom Pie, Net Wt. 6 OZ, packaged in a paper carton, Keep Frozen
Produce·1,235 affected·Oct 16, 2018
High RiskFDA
Buddy's Kitchen Inc
Huevos Rancheros Style Benedict with Seasoned Black Beans, Item 70614. Net Weight 9.60 lbs. 24-6.40 oz. portions. Keep Frozen. For in...
Frozen Food·7,789 affected·Oct 16, 2018
High RiskFDA
Bakkavor Foods Usa, Inc.
Trader Joe's Hummus quartet; 20 oz. plastic container; Spicy Hummus Roasted Garlic Hummus, Regular Hummus and Tomato Basil Hummus. P...
Produce·47,892 affected·Oct 16, 2018
High RiskFDA
Buddy's Kitchen Inc
Beef Barbacoa on Panini Focaccia, Item 70659. Net Weight 14.85 lbs. 36 - 6.60 oz. portions. Keep Frozen. For institutional use only. ...
Meat & Poultry·1,279 affected·Oct 16, 2018
High RiskFDA
Buddy's Kitchen Inc
Beef Barbacoa on Telera, Item 70663. Net Weight 13.92 lbs. 33 - 6.75 oz. portions. Keep Frozen. For institutional use only. Buddy's ...
Meat & Poultry·1,488 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxe...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipettin...
Diagnostic Devices·1,649 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name o...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Canon Medical System, Usa, Inc.
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general pu...
Medical Devices·46 affected·Oct 16, 2018
High RiskFDA
Carl Zeiss Meditec, Inc.
The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high ...
Medical Devices·151 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Steri...
Medical Devices·49,130 affected·Oct 16, 2018