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High RiskFDA
Dr. Reddy's Laboratories, Inc.
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-...
Oral Drugs·31,802 affected·Aug 6, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Medical Devices·927 affected·Aug 6, 2024
High RiskFDA
Pbm Nutritionals, Llc
CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case;...
Dairy·16,500 affected·Aug 5, 2024
High RiskFDA
Zeco Llc
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold...
Drugs·604 affected·Aug 5, 2024
High RiskFDA
Zeco Llc
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), ...
Drugs·0 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Medical Devices·8 affected·Aug 5, 2024
High RiskFDA
Howmedica Osteonics Corp.
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Medical Devices·1 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Medical Devices·9 affected·Aug 5, 2024
High RiskFDA
Quantum Surgical Sas
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of...
Respiratory Devices·2 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Medical Devices·788 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080;
Medical Devices·11,236 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Medical Devices·1,889 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Medical Devices·705 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402;
Medical Devices·39 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Medical Devices·286 affected·Aug 5, 2024
High RiskFDA
Ge Healthcare
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Medical Devices·2,138 affected·Aug 5, 2024
High RiskFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Medical Devices·11,576 affected·Aug 5, 2024
High RiskFDA
Reser's Fine Foods, Inc.
UPC 71117 14743, Reser s Rotisserie Chicken Salad Base 2lb. (32oz), refrigerated, packaged in an opaque plastic tub with a white printed ...
Meat & Poultry·38 affected·Aug 2, 2024
High RiskFDA
Reser's Fine Foods, Inc.
UPC 71117 19063, Reser's American Classics Garden Pasta Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plasti...
Produce·278 affected·Aug 2, 2024
High RiskFDA
Reser's Fine Foods, Inc.
UPC 78742 12653, Walmart Original Freshness Guaranteed Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed la...
Produce·7 affected·Aug 2, 2024
High RiskFDA
Reser's Fine Foods, Inc.
UPC 71117 19084, Reser's American Classics Spicy Pickle Potato Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a...
Produce·1 affected·Aug 2, 2024
High RiskFDA
Reser's Fine Foods, Inc.
UPC 78742 02670, Walmart Original Freshness Guaranteed Macaroni Salad 3lb. (48oz), refrigerated, packaged in an opaque printed plastic tu...
Produce·283 affected·Aug 2, 2024
High RiskFDA
Reser's Fine Foods, Inc.
UPC 95515 04502, Amazon Fresh Fresh Classic Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top...
Produce·16 affected·Aug 2, 2024
High RiskFDA
Empower Clinic Services Llc
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: ...
Injectable Drugs·2,797 affected·Aug 2, 2024
High RiskFDA
Ultradent Products, Inc.
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/...
Medical Devices·2,450 affected·Aug 2, 2024
High RiskFDA
Auris Health Inc
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Medical Devices·176 affected·Aug 2, 2024
High RiskFDA
Ultradent Products, Inc.
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Desc...
Medical Devices·560 affected·Aug 2, 2024
High RiskFDA
J F C International Inc
J-Basket Brand, Napa Kimchi, Net Wt. 14.1oz. plastic jar container (12 jars per case).
Food·2,735 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintain...
Medical Implants·77 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended f...
Medical Implants·6 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·133 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining eso...
Medical Implants·507 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining...
Medical Implants·79 affected·Aug 1, 2024
High RiskFDA
Becton Dickinson & Co.
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically signif...
Medical Devices·4,295 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esop...
Medical Implants·516 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·308 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·79 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·145 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for...
Medical Implants·7 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·146 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·39 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin...
Medical Implants·66 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·305 affected·Aug 1, 2024
High RiskFDA
Becton Dickinson & Co.
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacter...
Medical Devices·764 affected·Aug 1, 2024
High RiskFDA
Outset Medical, Inc.
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in ...
Medical Devices·2,422 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for...
Medical Implants·18 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin...
Medical Implants·2 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining eso...
Medical Implants·364 affected·Aug 1, 2024