Data Foundry

Medical device recalls 2018

Heron toilet and bath chair Model 880505-01 & 880505-11 — Class II medical device recall Z-0441-2019

Ongoing recall by R82 A/S, reported 2018-11-21, distributed nationwide. Replacement campaign on all units that have a gas spring head in aluminum.

Recall numberZ-0441-2019
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmR82 A/S, Gedved, Denmark
Recall initiated2017-06-30
Classified2018-11-09
Reported by FDA2018-11-21
DistributedNationwide (US)
Countries outside the USAU, CH, DE, DK, ES, FI, FR, GB, JP, NL, NO, NZ, PL
Quantity687
Serial numbers309658, 310007, 319209, 319822, 319823, 319824, 319825, 319826, 319827, 319829, 319830, 319831, 330695, 330696, 330697, 331862, 331914, 332387, 332586, 332587, 332589, 333755, 333761, 333762, 334833 and 5 more
Model numbers880505-01, 880505-11

Product

Heron toilet and bath chair Model 880505-01 & 880505-11

Reason for recall

Replacement campaign on all units that have a gas spring head in aluminum.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0441-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.