Skip to main content
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
RecallFDA
Faribault Foods, Inc.
S & W White Beans, Net Wt 15 oz (425g), UPC 72273-38807. Distributed by Faribault Foods, 1818 2nd Ave NW, Faribault, MN 55021-3035.
Food·2,700 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
CriticalFDA
D & D Foods, Inc.
Hy-Vee Spinach, Tomato, Mozzarella Twice Baked Potatoes, Net Wt. 5 oz wrapped in clear plastic.
Produce·13,457 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
High RiskFDA
Med-el Elektromedizinische Gereate, Gmbh
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; ...
Medical Implants·7 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, In...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
Surgical Devices·1 affected·Oct 16, 2018
High RiskFDA
Conformis, Inc.
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Medical Devices·1 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Aso, Llc
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x...
Medical Devices·218 affected·Oct 16, 2018
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which...
Medical Devices·49,130 affected·Oct 16, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetti...
Diagnostic Devices·1,628 affected·Oct 16, 2018
High RiskFDA
Request Foods Incorporated
Kashi, Fire Roasted Quinoa Bowl 9.5oz. UPC 18627 10769 Frozen 8, 9.5oz. units per case
Frozen Food·3,372 affected·Oct 15, 2018
High RiskFDA
Request Foods Incorporated
Kashi, Creamy Cashew Noodle Bowl 8oz. UPC 18627 10767 Frozen 8, 8oz. units per case
Frozen Food·37,561 affected·Oct 15, 2018
High RiskFDA
Request Foods Incorporated
PC Presidents Choice Roasted Vegetable Lasagna 1.13kg. UPC 60383 75647 Frozen 12 units per case
Produce·4,352 affected·Oct 15, 2018
High RiskFDA
Caito Foods Llc.
SOUTHWEST SWEET POTATO RICE; 12oz. Plastic Clamshell; Keep Refrigerated; UPC 0826766185610
Food·920 affected·Oct 15, 2018
High RiskFDA
Diamond Crystal Brands, Inc.
HOUSE BLEND Barbecue SAUCE INGREDIENTS: ***Contains 2% or less of Soybean Oil***Onion Powder***Calcium Disodium EDTA***DIAMOND CRYSTAL BR...
Produce·10,680 affected·Oct 15, 2018
High RiskFDA
Caito Foods Llc.
SOUTHWEST STUFFED PORTABELLA MUSHROOM; 8oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0081851202676
Food·220 affected·Oct 15, 2018
High RiskFDA
Request Foods Incorporated
Jenny Craig Butternut Squash Ravioli 7.5oz. UPC 55447 00625 Frozen 30, 7.5oz. units per case
Dairy·11,687 affected·Oct 15, 2018
High RiskFDA
Caesar's Pasta, Llc
Caesars Sweet Potato Ravioli Samples
Food·4 affected·Oct 15, 2018
High RiskFDA
Mineralife Llc
Trace Minerals Dietary Supplement , 16.2 fl oz (480 mL) bottles, Packaged in dark blue plastic bottles, For freshness, keep refrigerated ...
Supplements·515 affected·Oct 15, 2018
High RiskFDA
Request Foods Incorporated
Kashi, Sweet Potato Quinoa Bowl 9oz. UPC 18627 10547 Frozen 8, 9oz. units per case
Frozen Food·72,539 affected·Oct 15, 2018
High RiskFDA
Request Foods Incorporated
Evol Butternut Squash & Sage Ravioli 18oz. UPC 91627 00776 Frozen 4, 18oz. units per case
Dairy·24,568 affected·Oct 15, 2018
High RiskFDA
Request Foods Incorporated
Evol Portabello Goat Cheese Ravioli 18oz UPC 91627 00789 Frozen 6, 18oz. units per case
Dairy·3,982 affected·Oct 15, 2018