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FDA Device Enforcement Reports
View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.
FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.
Philips L12-5 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit SKU DYKS1192C; 9) MEDLINE PEDIATRIC PATIENT PACK, Medline kit SKU DYKS1199B; 10) MEDLINE ADULT PATIENT PACKAGE, Medline kit SKU DYKS1200B; 11) GERMANTOWN PRE OP KIT, Medline kit SKU DYKS1248; 12) GERMANTOWN PRE OP BLOCK KIT, Medline kit SKU DYKS1249; 13) PRE OP KIT, Medline kit SKU DYKS1274A; 14) CATH LAB PRE OP START KIT, Medline kit SKU DYKS1324; 15) PRE OP KIT, Medline kit SKU DYKS1376; 16) PTC KIT, Medline kit SKU DYNDH1161A; 17) DR BROWN BODY, Medline kit SKU DYNJ910487.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·January 21, 2026
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 25, 2026
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 18, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 11, 2026
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
FDA Enforcement
Class II
·Ongoing·ETAC A/S·February 11, 2026
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA Enforcement
Class II
·Ongoing·VANTIVE US HEALTHCARE LLC·February 11, 2026