FDA Medical Device Recalls (openFDA)
R82 A/S: Heron toilet and bath chair Model 880505-01 & 880505-11
- Recall number
- Z-0441-2019
- Recalling firm
- R82 A/S
- Product
- Heron toilet and bath chair Model 880505-01 & 880505-11
- Status
- Open, Classified
- Initiated
- 2017-06-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- Replacement campaign on all units that have a gas spring head in aluminum.
- 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
- 687
- Distribution
- Nationwide Denmark, Germany, Spain, Finland, France, Great Britain, Island, Netherlands, Norway, Poland, Switzerland, Japan, Australia and New Zealand
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- INM
- Firm FEI
- 3001657382
- Firm city
- Gedved
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28