Z-0441-2019Class II

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

Name: Z-0441-2019 Heron toilet and bath chair Model 880505-01 & 880505-11
Creator: R82 a/s
Published: 2017-06-30
License: https://open.fda.gov/license/

R82 a/S / initiated 2017-06-30 / Open, Classified

FDA source

R82 A/S began a recall of Heron toilet and bath chair Model 880505-01 & 880505-11 on 2017-06-30. FDA classified it as Class II and gives the reason as "Replacement campaign on all units that have a gas spring head in aluminum". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0441-2019
Classification: Class II
Status: Open, Classified
Initiated: 2017-06-30
Posted: 2018-11-09
Recalling firm: R82 a/S
Product: Heron toilet and bath chair Model 880505-01 & 880505-11
Product code: INM Chair, With Casters
Reason for recall: Replacement campaign on all units that have a gas spring head in aluminum.
FDA root cause: Other
Action: The firm sent a letter ask you to replace the gas spring heads on these Herons the replacement kits are being sent to your attention. Please carry out the required retrofitting yourself or forward the kits and instructions to those that maintain the product on your behalf. This replacement must take place as soon as you possibly can and no later than 31-12-2017 and the reporting form documenting this must be filled in for each unit and returned to R82 A/S.
Quantity in commerce: 687
Distribution: Nationwide Denmark, Germany, Spain, Finland, France, Great Britain, Island, Netherlands, Norway, Poland, Switzerland, Japan, Australia and New Zealand
Product codes and lots: Serial Numbers: 309658, 310007, 319209, 319822, 319823, 319824, 319825, 319826, 319827, 319829, 319830, 319831, 330695, 330696, 330697, 331862, 331914, 332387, 332586, 332587, 332589, 333755, 333761, 333762, 334833, 342515, 342518, 342523, 345084, 345085

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0441-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0441-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-11-21	2018-11-09

Product code INM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)