Devices (MDR) · 2026-10-23 · 1 added, 0 removed
Devices (MDR) update: 2026-10-23
Detected by our Compliance Monitor on 2026-10-28. Entries tracked under Regulation (EU) 2017/745, field safety notices and recalls at this revision: 1.
+ Added (1)
- STOMAHESIVE PASTE (1TUBEX56.7G) US — ConvaTec Inc · Urgent field safety notice; corrective-action details were not available in the indexed result. The product is categorized as a dressing/pad ointment or gel and is not clearly within the specified tattoo or piercing device categories.
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.
See also: REACH Monitor home · All Devices (MDR) updates · Official source ↗