Devices (MDR) · 2026-04-22 · 1 added, 0 removed

Devices (MDR) update: 2026-04-22

Name: Regulation (EU) 2017/745, field safety notices and recalls delta, 2026-04-22
Creator: Poli International Co., Ltd
Published: 2026-04-22
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 2026-09-02. Entries tracked under Regulation (EU) 2017/745, field safety notices and recalls at this revision: 1.

Notice date: 2026-04-22

Detected: 2026-09-02

Total tracked: 1 ↗

+ Added (1)

O&M Halyard Inc. — HALYARD PUREZERO Ultraviolet Nitrile Exam Glove · Urgent field safety notice / recall for a medical exam glove; product did not meet chemical permeation performance specifications, and consignees were instructed to review inventory and communicate the recall to staff.

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.