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CriticalFDA
Captain Rusty's Seafood Products Llc
Captain Rusty's Blue Crab Dip, Made with real Blue Crab meat, Keep Refrigerated,16 oz.
Meat & Poultry·0 affected·May 21, 2020
CriticalFDA
Captain Rusty's Seafood Products Llc
Captain Rusty's Cajun Crab & Lobster Dip, Made with real Blue Crab and Lobster meat, Keep Refrigerated,16 oz.
Meat & Poultry·0 affected·May 21, 2020
High RiskFDA
Captain Rusty's Seafood Products Llc
Captain Rusty's Smoked Salmon Dip, A Taste of the Pacific Coast, Keep Refrigerated, 16 oz.
Seafood·0 affected·May 21, 2020
High RiskFDA
Vitalconnect Inc.
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display phys...
Medical Devices·7 affected·May 21, 2020
High RiskFDA
La Sonorense, Inc.
La Sonorense Tortilla Factory, Flour Burrito Size, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.)
Food·40 affected·May 20, 2020
High RiskFDA
La Sonorense, Inc.
La Sonorense Tortilla Factory, Gorditas Sonora Style, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.)
Food·247 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Medical Devices·2,123 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Diagnostic Devices·779 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
Medical Devices·2,123 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Medical Devices·130 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Medical Devices·2,123 affected·May 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Medical Devices·353 affected·May 20, 2020
CriticalFDA
Bake'n Joy Foods, Inc.
Sienna brand 4.25 oz. Cranberry Orange Muffins coded 20 071 31B
Produce·48 affected·May 19, 2020
High RiskFDA
Wuhan Bingbing Pharmaceutical Co., Ltd.
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 8...
Topical Drugs·54,000 affected·May 19, 2020
High RiskFDA
Wuhan Bingbing Pharmaceutical Co., Ltd.
Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
Topical Drugs·1,800 affected·May 19, 2020
High RiskFDA
Wuhan Bingbing Pharmaceutical Co., Ltd.
Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Dr...
Topical Drugs·72,600 affected·May 19, 2020
RecallFDA
Flexion Therapeutics, Inc.
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufact...
Injectable Drugs·792 affected·May 19, 2020
High RiskFDA
Wuhan Bingbing Pharmaceutical Co., Ltd.
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-52...
Topical Drugs·4,960 affected·May 19, 2020
High RiskFDA
American Health Packaging
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, O...
Oral Drugs·15,755 affected·May 19, 2020
High RiskFDA
Roi Cps Llc
Respirator Crash Cart Kit
Respiratory Devices·200 affected·May 19, 2020
High RiskFDA
Philips North America, Llc
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen satura...
Respiratory Devices·1 affected·May 19, 2020
High RiskFDA
Roi Cps Llc
Isolation Droplet Bundle Kit
Medical Devices·24 affected·May 19, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to ...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to a...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Nu...
Medical Devices·89,109 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tre...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer trea...
Medical Devices·0 affected·May 18, 2020
High RiskFDA
Carefusion 2200 Inc
Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Surgical Devices·358 affected·May 18, 2020
High RiskFDA
Cell-nique Corp
Cherrybrook Kitchen***Gluten Free***Wheat Free***SUGAR COOKIE MIX***NET WT. 13 OZ
Bakery & Grains·1 affected·May 16, 2020
High RiskFDA
Wegmans Food Markets, Inc.
Wegmans Tuna Salad, 16 OZ (1 LB) 454 g; UPC: 77890-48147; SELL BY 5/21/20
Seafood·958 affected·May 15, 2020
High RiskFDA
U.s. Tov, Inc.
Dragonfly brand Galanga Powder; Net Weight: 5 oz. (142 g) UPC: 7 21557 53337 6 Product of Thailand Distributed by U.S. Trading Comp...
Food·100 affected·May 15, 2020
High RiskFDA
Wegmans Food Markets, Inc.
Wegmans Tuna Salad on Roasted Tomato Pita, 9 oz.; UPC: 2-27390-00000; SELL BY 5/14-5/16
Seafood·958 affected·May 15, 2020
High RiskFDA
Garza Food Ventures
Siete Grain Free Cashew Flour Tortillas NET WT 7 OZ (200g) 8 Count UPC 865336000045 packaged in flexible plastic
Food·7,260 affected·May 15, 2020
High RiskFDA
Triova Pharmaceuticals Llc
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
Drugs·210 affected·May 15, 2020
High RiskFDA
Eco Lips Inc
EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion...
Drugs·68,400 affected·May 15, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (...
Oral Drugs·14,030 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervic...
Medical Devices·2,735 affected·May 15, 2020
High RiskFDA
Mediana Co., Ltd.
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (N...
Respiratory Devices·180 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the...
Medical Devices·1,965 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appr...
Medical Devices·730 affected·May 15, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management Sys...
Medical Devices·186 affected·May 15, 2020