Skip to main content
High RiskFDA
Alcon Research Llc
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
Medical Devices·1,061 affected·Jul 15, 2024
High RiskFDA
Alcon Research Llc
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
Medical Devices·1,057 affected·Jul 15, 2024
High RiskFDA
Omnia Medical
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Medical Devices·15 affected·Jul 15, 2024
High RiskFDA
Intuitive Surgical, Inc.
Ion Endoluminal System, REF: 380748-65
Medical Devices·3 affected·Jul 12, 2024
High RiskFDA
Ge Healthcare (china) Co., Ltd.
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5)...
Medical Devices·3,572 affected·Jul 12, 2024
High RiskFDA
Meddev Corp
Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Wei...
Medical Implants·34 affected·Jul 12, 2024
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, ...
Diagnostic Devices·30 affected·Jul 12, 2024
High RiskFDA
Urban Outfitters Inc.
Elin Dessert Plates. The recalled plates are lilac in color with orange mushroom, moth, and fern motifs. The plates measure 21 cm (8.25 i...
Food·3,757 affected·Jul 11, 2024
High RiskFDA
Medtronic Inc.
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 20...
Medical Devices·18,788 affected·Jul 11, 2024
High RiskFDA
Pacific Shellfish, Inc
Signature Blue Swimming Crab Claw and Lump 1lb can Tin Can, Lot # 78821 Expiration June 09th 2026, Lot # 788454 Expiration June 09th 2026
Seafood·21 affected·Jul 10, 2024
High RiskFDA
Beckman Coulter Mishima K.k.
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combinatio...
Diagnostic Devices·24 affected·Jul 10, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumor...
Medical Devices·19 affected·Jul 10, 2024
High RiskFDA
Bard Peripheral Vascular Inc
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis...
Surgical Devices·625 affected·Jul 10, 2024
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnos...
Diagnostic Devices·170 affected·Jul 10, 2024
High RiskFDA
Kalo Foods, Llc
All Natural KALO Chocolate Cake Gluten Free, UPC 8 53407 00418 4, Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
Bakery & Grains·84 affected·Jul 9, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt....
Oral Drugs·5,752 affected·Jul 9, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Medical Devices·290 affected·Jul 9, 2024
High RiskFDA
Carefusion 303, Inc.
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
Medical Devices·0 affected·Jul 9, 2024
High RiskFDA
Covidien
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Medical Devices·68,093 affected·Jul 9, 2024
High RiskFDA
Dkk Dai-ichi Shomei Co., Ltd.
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field a...
Surgical Devices·555 affected·Jul 9, 2024
High RiskFDA
Integra Lifesciences Corp.
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Nav...
Surgical Devices·265 affected·Jul 9, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions...
Medical Devices·35 affected·Jul 8, 2024
High RiskFDA
Lunds Mitchell Rd Llc
Lunds & Byerlys pesto salmon and lemon rice. UPC 18169-66396. Net Wt. 12 oz. (340.2g). Keep Refrigerated.
Seafood·76 affected·Jul 5, 2024
High RiskFDA
Orthopediatrics Canada Ulc Dba Pega Medical
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Medical Devices·6 affected·Jul 4, 2024
High RiskFDA
Tailstorm Health Inc
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by M...
Injectable Drugs·12,525 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and admin...
Cardiac Devices·3 affected·Jul 3, 2024
High RiskFDA
W.l. Gore & Associates, Inc.
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Medical Devices·51 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnost...
Cardiac Devices·7 affected·Jul 3, 2024
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Diagnostic Devices·18,467 affected·Jul 3, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a d...
Cardiac Devices·2 affected·Jul 3, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Roscas packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Concha Mexicana packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Champurradas packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Casco packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Sheca Anis packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Cortado Rojo packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Curenitos packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Churros packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Sheca Redonda packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Gusano packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Corona packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Liso packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Conchas Guatemala packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Panaderia Guatemex
Panaderia Guatemex - Besos packaged in plastic bag
Food·170 affected·Jul 2, 2024
High RiskFDA
Sun Pharmaceutical Industries Inc
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by...
Injectable Drugs·2,088 affected·Jul 2, 2024
High RiskFDA
Stryker Sustainability Solutions
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Medical Devices·38,850 affected·Jul 2, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Medical Devices·26 affected·Jul 2, 2024
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Medical Devices·333 affected·Jul 2, 2024