Devices (MDR) · 2026-08-24 · 4 added, 0 removed

Devices (MDR) update: 2026-08-24

Name: Regulation (EU) 2017/745, field safety notices and recalls delta, 2026-08-24
Creator: Poli International Co., Ltd
Published: 2026-08-24
License: https://creativecommons.org/licenses/by/4.0/
Keywords: MDR, 2017/745, field safety notice, FSCA, recall, needles, sterile devices, compliance

Detected by our Compliance Monitor on 2026-08-26. Entries tracked under Regulation (EU) 2017/745, field safety notices and recalls at this revision: 4.

Notice date: 2026-08-24

Detected: 2026-08-26

Total tracked: 4 ↗

+ Added (4)

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR / Medtronic Perfusion Systems · FDA recall notice for a cannula device; affected units were to be removed from use/sale due to a product issue.
EOPA 3D Arterial Cannula 22FR / Medtronic Perfusion Systems · FDA recall notice for a cannula device; affected units were to be removed from use/sale due to a product issue.
Urgent Field Safety Notice for Einweg-Nadelführung (Disposable Needle Guide) / WellGo Medical Products GmbH · BfArM FSN for a disposable needle guide; the notice reflects a field safety corrective action in Germany.
Urgent Field Safety Notice for Imager II Angiographic Catheter / Boston Scientific Corporation Natick · BfArM FSN for a catheter; the notice reflects a field safety corrective action in Germany.

What this means for studios

A field safety corrective action (FSCA) or recall means the manufacturer has identified a risk in specific lots of a device. If you stock an affected product, check the lot numbers on your boxes against the notice, quarantine matching stock immediately, and contact your distributor for replacement. Keep the notice reference in your studio records: it documents that you acted on the date the issue became known.