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High RiskFDA
Boston Scientific Corporation
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposu...
Medical Devices·8,524 affected·Apr 15, 2021
High RiskFDA
Haag-streit Usa Inc
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Medical Devices·0 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and...
Medical Devices·4,549 affected·Apr 15, 2021
High RiskFDA
Michael Zakany Llc
Jose Madrid Salsa - Strawberry Mild Salsa 13oz glass jars, 12 jars per case
Produce·6,659 affected·Apr 14, 2021
High RiskFDA
Champlain Chocolate Company
Organic Mr. Goodtime Bunny***NET WT 3.35 LBS (1.4kg)***INGREDIENTS: *Milk, *Dark, AND *WHITE CHOCOLATE (*SUGAR, *MILK POWDER, *COCOA BUTT...
Dairy·443 affected·Apr 14, 2021
High RiskFDA
Reser's Fine Foods, Inc.
Freshness Guaranteed Macaroni Salad Amish, item # 579284, refrigerated, packaged in a clear cup with clear snap on lid, net wt. 32 oz. UP...
Produce·16,614 affected·Apr 14, 2021
High RiskFDA
Champlain Chocolate Company
"Basket Country Bunny ORG" that contains the Organic Mr. Goodtime Bunyy***NET WT 3.35 LBS (1.4kg)***INGREDIENTS: *Milk, *Dark, AND *WHITE...
Dairy·443 affected·Apr 14, 2021
High RiskFDA
Shearer's Snacks
Raley's Salt & Vinegar Flavored Potato Chips 9.5oz flexible plastic packaging 11 bags per case
Snacks & Candy·420 affected·Apr 14, 2021
High RiskFDA
Blount Fine Foods Corporation
Panera Lobster Bisque, 16 oz.
Seafood·17,992 affected·Apr 14, 2021
High RiskFDA
Fresenius Medical Care, North America
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60...
Drugs·709 affected·Apr 14, 2021
High RiskFDA
Beckman Coulter Inc.
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Medical Devices·1,034 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
E3800 PC Units (spare parts)
Medical Devices·965 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Medical Devices·3,346 affected·Apr 14, 2021
High RiskFDA
Torn & Glasser, Inc.
Dark Chocolate Expresso Beans; Net Wt. 12 oz. (340g), Best if used by 11-19-2021. Contains Soy, May Contain Milk. Packed in a facil...
Dairy·622 affected·Apr 13, 2021
High RiskFDA
Snak King Corporation
Trader Joe's Restaurant Style White Corn Tortilla Chips; Net Wt. 9 oz. (255g)
Snacks & Candy·8,825 affected·Apr 13, 2021
High RiskFDA
Mountain West Mothers' Milk Bank Inc.
Mountain West Mothers' Milk Bank - Pasteurized Donor Human Milk, 3 fluid ounce BPA free plastic bottles, embossed with "Donor Human Milk"...
Dairy·140 affected·Apr 13, 2021
High RiskFDA
Philips North America Llc
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Medical Devices·2 affected·Apr 13, 2021
High RiskFDA
Backcountry Mills Llc
G4G Low Carb Pancake & Waffle Mix, Keto Friendly Just Add Water Net Wt 12 ounces, 6pack Case UPC 860000241427 packaged in a rigid cardboa...
Bakery & Grains·2,016 affected·Apr 12, 2021
High RiskFDA
Ample Hills Manufacturing Llc.
Ample Hills Creamery Chocolate Milk and Cookies Ice Cream, 14 oz.
Dairy·1,316 affected·Apr 12, 2021
High RiskFDA
Preferred Pharmaceuticals, Inc.
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Pre...
Oral Drugs·0 affected·Apr 12, 2021
High RiskFDA
Edge Pharma, Llc
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMI...
Topical Drugs·5,850 affected·Apr 12, 2021
High RiskFDA
Dj Orthopedics De Mexico S.a. De C.v.
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes...
Medical Devices·0 affected·Apr 12, 2021
High RiskFDA
Hostess Brands Llc
Hostesss SnoBalls packaged as Hostess Chocolate CupCakes, Net Wt 3.17 OZ, UPC 8 88109 01001 0, Hostess Brands, LLC Kansas City, MO
Bakery & Grains·648 affected·Apr 10, 2021
High RiskFDA
Teligent Pharma, Inc.
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Topical Drugs·3,432 affected·Apr 9, 2021
High RiskFDA
Natrol, Llc
Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20...
Food·12,740 affected·Apr 8, 2021
High RiskFDA
J F C International Inc
J-Basket Premium Korean Seaweed Snack - Wasabi flavor on outer wrap for 3 inner packages Inner packages labeled J-Basket Premium Seaweed ...
Snacks & Candy·451 affected·Apr 8, 2021
High RiskFDA
Spes Medica
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached...
Surgical Devices·34 affected·Apr 8, 2021
High RiskFDA
Meridian Bioscience Inc
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative t...
Medical Devices·376 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuo...
Surgical Devices·20 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Medical Devices·3 affected·Apr 8, 2021
High RiskFDA
Windstone Medical Packaging, Inc.
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS...
Surgical Devices·114 affected·Apr 8, 2021
High RiskFDA
Snowville Creamery, Llc
Snowville Creamery Whipping Cream 64oz Paperboard Carton Sold as individual Units
Dairy·297 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is desig...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed fo...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)108...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UD...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed fo...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, ...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)1...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Diagnostic Devices·10 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is d...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some servic...
Medical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)108...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Bard Access Systems Inc.
REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10...
Surgical Devices·0 affected·Apr 7, 2021
High RiskFDA
Twin City Foods, Inc.
Signature Select Golden Corn Sweet, frozen, packed in poly film bags. 12/16 oz. packages per case. UPC 2113009152. Signature Select Gold...
Frozen Food·90 affected·Apr 6, 2021
High RiskFDA
Hyobin Llc
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
Oral Drugs·500 affected·Apr 6, 2021