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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.
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
FDA Enforcement
Class II
·Ongoing·TANGENT ENDOSCOPY, LLC·May 27, 2026
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·May 13, 2026
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
FDA Enforcement
Class II
·Ongoing·Milestone S.R.L.·May 6, 2026
Atlan A350. Model Number: 8211500. anesthesia workstation
FDA Enforcement
Class I
·Ongoing·Draeger, Inc.·June 10, 2026
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 6, 2026
Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·June 10, 2026
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·May 13, 2026
Heraeus, PALAMIX duo. Material Number: 66057897.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026