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CriticalFDA
Taylor Farms Retail, Inc.
Salad Kit labeled as follows: Taylor FARMS Honey Balsamic SALAD KIT, NET WT. 8.3 OZ (235g), INGREDIENTS: HONEY BALSAMIC VINAIGRETTE (soyb...
Dairy·8,284 affected·Aug 21, 2025
CriticalFDA
Medline Industries, Lp
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Medical Devices·828 affected·Aug 21, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L211 PROPONENT DR SL MRI Pacemaker
Cardiac Devices·106,536 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number S702, ALTRUA 2 DR SL Pacemaker
Cardiac Devices·4,055 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U128, VALITUDE CRT-P EL MRI
Medical Devices·28,911 affected·Aug 20, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Package...
Cardiac Devices·71 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L231, PROPONENT DR EL MRI Pacemaker
Cardiac Devices·63,851 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L101, ESSENTIO DR SL Pacemaker
Cardiac Devices·22,714 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Cardiac Devices·3,146 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U226, VISIONIST CRT-P EL
Medical Devices·1,050 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
PROPONENT SR SL (Model L200)
Medical Devices·1,380 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Medical Devices·41,191 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L221 PROPONENT DR EL Pacemaker
Cardiac Devices·3,592 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Cardiac Devices·190,088 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Medical Devices·34,180 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L121 ESSENTIO DR EL Pacemaker
Cardiac Devices·10,833 affected·Aug 20, 2025
CriticalFDA
B Braun Medical Inc
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Injectable Drugs·47,148 affected·Aug 18, 2025
CriticalFDA
B Braun Medical Inc
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Injectable Drugs·46,032 affected·Aug 18, 2025
CriticalFDA
New Acai Amazonas Llc
Organic Mango Freeze Dried Powder, Bulk, 15-kilogram boxes (2 packs of 7.5 kilograms in a carton box), 7.5kg packaged in multi-wall kraft...
Food·255 affected·Aug 15, 2025
CriticalFDA
Fresh & Ready Foods Llc
Tuscan Artichoke and Mozzarella Salad; Keep Refrigerated, NET WT: 8.5 OZ, UPC# 6 82906 90935 1 Manufactured by Fresh and Ready Foods LLC...
Produce·233 affected·Aug 13, 2025
CriticalFDA
Fresh & Ready Foods Llc
Spanish Club Ciabatta; Keep Refrigerated, NET WT: 10.5 OZ, UPC# 6 82906 90933 7 Manufactured by Fresh and Ready Foods LLC, San Fernando,...
Food·233 affected·Aug 13, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Grilling Camembert with Tapenade & Roasted Tomatoes - 10 OZ - Overwrapped black and gold metal tray UPC: 2-77297-XXXXX-0 (X - ...
Produce·4,884 affected·Aug 12, 2025
CriticalFDA
Quesito El Establo
Quesito El Establo brand Spanish Cheese QUESITO COLOMBIANO; INGREDIENTS: Milk, Cheese Cultures, Salt, Vitamins C and D; INGREDIENTES: Lec...
Dairy·800 affected·Aug 12, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Medium Camembert Soft Ripened Cheese - 8.8oz - Round wooded container; UPC: 2-77467-00000-7 , 0-77890-53515-8
Dairy·4,884 affected·Aug 12, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Assorted Cheese Flight - Varies (sold by the lb) - Black Plastic container with clear lid UPC: 2-77100-XXXXX-5 (X - varies by ...
Dairy·4,884 affected·Aug 12, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Caramel Apple Pecan Topped Brie Cheese -Small - 13 OZ - Clear plastic container with lid UPC: 2-77645-XXXXX-3 (X - varies by w...
Dairy·4,884 affected·Aug 12, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Ass...
Medical Devices·8,413 affected·Aug 12, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assis...
Medical Devices·25,389 affected·Aug 12, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assi...
Medical Devices·15,834 affected·Aug 12, 2025
CriticalFDA
Fromi Usa
Brie Royal Faucon; Net Weight about: 2.2lb/ 1kg LOT AUS/US
Food·52 affected·Aug 11, 2025
CriticalFDA
Medline Industries, Lp
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Medical Devices·88 affected·Aug 8, 2025
CriticalFDA
Medline Industries, Lp
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Medical Devices·22 affected·Aug 8, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Cardiac Devices·41,200 affected·Aug 6, 2025
CriticalFDA
Olympus Corporation Of The Americas
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of fou...
Medical Devices·104,508 affected·Aug 6, 2025
CriticalFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Cardiac Devices·25,261 affected·Aug 6, 2025
CriticalFDA
Neuhaus Nv
NEUHAUS brand ORIGINAL BELGIAN CHOCOLATE; POPPING MILK CHOCOLATES WITH COOKIES; 4.23 oz - 120g; (EN)Chocolates - INGREDIENTS: milk chocol...
Dairy·100 affected·Aug 4, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Medical Devices·10,101 affected·Aug 4, 2025
CriticalFDA
Baxter Healthcare Corporation
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
Medical Devices·43,922 affected·Aug 4, 2025
CriticalFDA
Medline Industries, Lp
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401...
Surgical Devices·7,913 affected·Jul 31, 2025
CriticalFDA
Medline Industries, Lp
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH ...
Cardiac Devices·7,913 affected·Jul 31, 2025
CriticalFDA
Medline Industries, Lp
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic...
Cardiac Devices·7,913 affected·Jul 31, 2025
CriticalFDA
Genogenix Llc
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW ...
Injectable Drugs·0 affected·Jul 30, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the ...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all W...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025