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CriticalFDA
Icu Medical, Inc.
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette ...
Medical Devices·23,203 affected·Oct 2, 2025
CriticalFDA
Doan's Dessert And Coffee
White Chocolate Coconut Bundt Cake - Net Weight 3 lbs 12 oz Contains: Wheat, Soy, Milk, Eggs No UPC
Dairy·4,050 affected·Oct 1, 2025
CriticalFDA
Doan's Dessert And Coffee
Carrot Bundt Cake - Net Weight 4 lbs Contains: Wheat, Soy, Milk, Eggs, Tree Nuts No UPC
Dairy·4,050 affected·Oct 1, 2025
High RiskFDA
Church & Dwight Co., Inc.
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237...
Drugs·21,912 affected·Oct 1, 2025
High RiskFDA
Aspiro Pharma Limited
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Cambe...
Injectable Drugs·0 affected·Oct 1, 2025
High RiskFDA
Philips Medical Systems Dmc Gmbh
Radiography 7300 C; Model Number: 712037;
Medical Devices·284 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower; Electr...
Surgical Devices·2 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electro...
Surgical Devices·58,499 affected·Oct 1, 2025
High RiskFDA
Philips Medical Systems Dmc Gmbh
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Diagnostic Devices·223 affected·Oct 1, 2025
High RiskFDA
Endomagnetics Ltd
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System i...
Surgical Devices·540 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; ...
Surgical Devices·18,117 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Elec...
Surgical Devices·1,446 affected·Oct 1, 2025
High RiskFDA
Philips Medical Systems Dmc Gmbh
Precision CRF; Model Number: 706400;
Medical Devices·42 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower; ...
Surgical Devices·9,547 affected·Oct 1, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1...
Cardiac Devices·10,153 affected·Oct 1, 2025
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Medical Devices·80 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Ele...
Surgical Devices·60,917 affected·Oct 1, 2025
High RiskFDA
Quest International, Inc.
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Ve...
Diagnostic Devices·0 affected·Oct 1, 2025
High RiskFDA
Philips Medical Systems Dmc Gmbh
ProxiDiagnost N90; Model Number: 706110;
Diagnostic Devices·41 affected·Oct 1, 2025
High RiskFDA
Medline Industries, Lp
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Elec...
Surgical Devices·65 affected·Oct 1, 2025
High RiskFDA
Abdallah Incorporated
Lunds & Byerly's Premium confections. Pecan Caramel Cluster Dipped in milk chocolate. Net Wt 2.5 oz (71g) UPC 0 72431-01294 5. Produc...
Dairy·744 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, RE...
Medical Devices·4,214 affected·Sep 30, 2025
High RiskFDA
Alcon Research Llc
Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
Medical Devices·82 affected·Sep 30, 2025
CriticalFDA
Impris Imaging Inc
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Medical Devices·0 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
Medical Devices·120 affected·Sep 30, 2025
High RiskFDA
Prismatik Dentalcraft, Inc.
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Numbe...
Medical Devices·208 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
Medical Devices·345 affected·Sep 30, 2025
CriticalFDA
Impris Imaging Inc
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Medical Devices·0 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
Medical Devices·142 affected·Sep 30, 2025
CriticalFDA
Carefusion 303, Inc.
BD Pyxis Pro MedStation Main, REF: 1155-00
Medical Devices·27 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Medical Devices·18 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ...
Medical Devices·2,844 affected·Sep 30, 2025
CriticalFDA
Carefusion 303, Inc.
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-0...
Medical Devices·2,755 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Medical Devices·424 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF C...
Medical Devices·11,032 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
Cardiac Devices·12 affected·Sep 30, 2025
CriticalFDA
Carefusion 303, Inc.
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Medical Devices·32 affected·Sep 30, 2025
High RiskFDA
Shenzhen Atomstack Technologies
Material Processing Laser Products
Medical Devices·0 affected·Sep 30, 2025
CriticalFDA
B Braun Medical Inc
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Vers...
Medical Devices·1,298,454 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Medical Devices·48 affected·Sep 30, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LA...
Medical Implants·28,679 affected·Sep 30, 2025
CriticalFDA
New Age International, Inc.
Signature brand Enoki Mushroom; 200g; clear plastic package
Food·175 affected·Sep 29, 2025
CriticalFDA
Eggs Unlimited Llc
Big Y Brown Jumbo A 12ct Eggs; UPC: 018894319146 Simple Truth Cage Free Brown Large AA 12ct; UPC: 011110797698 Stater Bros Cage Free Larg...
Food·92,476 affected·Sep 29, 2025
High RiskFDA
Acella Pharmaceuticals, Llc
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, N...
Oral Drugs·4,680 affected·Sep 29, 2025
High RiskFDA
Acuity Specialty Products, Inc.
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll...
Drugs·0 affected·Sep 29, 2025
High RiskFDA
Medline Industries, Lp
Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use ...
Drugs·222,800 affected·Sep 29, 2025
High RiskFDA
Acuity Specialty Products, Inc.
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, ...
Drugs·0 affected·Sep 29, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Medical Devices·29 affected·Sep 29, 2025