Core noun
Recalled products
The canonical enforcement rows. Everything else groups, enriches, or interprets these records.
Indexed record set
86,536 products
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- Product
- GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC: 747599662003
- Firm
- Ghirardelli Chocolate Company
- Event
- Event 98851
- Initiated
- April 26, 2026
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- Product
- GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 10lbs (4.54kg) Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 30LB (13.62kg) Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC (50oz): 747599662010 UPC (10lbs): 747599662034 UPC (30lbs): 747599419027
- Firm
- Ghirardelli Chocolate Company
- Event
- Event 98851
- Initiated
- April 26, 2026
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- Product
- GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Firm
- GE Medical Systems Information Technologies Inc
- Event
- Event 98938
- Initiated
- April 24, 2026
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- Product
- GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Firm
- GE Medical Systems Information Technologies Inc
- Event
- Event 98938
- Initiated
- April 24, 2026
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- Product
- GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Firm
- GE Medical Systems Information Technologies Inc
- Event
- Event 98938
- Initiated
- April 24, 2026
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- Product
- GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Firm
- GE Medical Systems Information Technologies Inc
- Event
- Event 98938
- Initiated
- April 24, 2026
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- Product
- GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Firm
- GE Medical Systems Information Technologies Inc
- Event
- Event 98938
- Initiated
- April 24, 2026
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- Product
- EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- Firm
- BERLIN HEART GMBH
- Event
- Event 98797
- Initiated
- April 24, 2026
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- Product
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Firm
- Devicor Medical Products Inc
- Event
- Event 98843
- Initiated
- April 24, 2026
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- Product
- GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Firm
- GE Medical Systems Information Technologies Inc
- Event
- Event 98938
- Initiated
- April 24, 2026
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- Product
- Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
- Firm
- Medartis AG
- Event
- Event 98952
- Initiated
- April 24, 2026
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- Product
- CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
- Firm
- GE Medical Systems Information Technologies Inc
- Event
- Event 98932
- Initiated
- April 24, 2026
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- Product
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
- Firm
- Intuitive Surgical, Inc.
- Event
- Event 98569
- Initiated
- April 24, 2026
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- Product
- Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;
- Firm
- Bayer Medical Care, Inc.
- Event
- Event 98881
- Initiated
- April 24, 2026
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- Product
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
- Firm
- Teva Pharmaceuticals USA, Inc
- Event
- Event 98810
- Initiated
- April 24, 2026
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- Product
- Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
- Firm
- Lupin Pharmaceuticals Inc.
- Event
- Event 98809
- Initiated
- April 24, 2026
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- Product
- Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
- Firm
- Lannett Company Inc.
- Event
- Event 98791
- Initiated
- April 24, 2026