FDA Medical Device Recalls (openFDA)
Penner Patient Care, Inc.: Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
- Recall number
- Z-1499-2026
- Recalling firm
- Penner Patient Care, Inc.
- Product
- Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
- Status
- Open, Classified
- Initiated
- 2025-08-13
- Posted
- 2026-03-09
- Terminated
- not on file
- Reason
- The device does not bear a unique device identifier.
- Root cause
- Error in labeling
- Action
- Recall notification letters were sent to customers beginning 8/13/25. Your facility has been identified as one that has purchased a Penner Bathing Spa and must place the label(s) attached to this letter(s) next to the current serial tag on your existing Penner Spa and, if applicable, Penner Reservoir. The existing serial tags are located on the side of the spa or reservoir. The serial tag is located behind the TV if you have a Penner Premier Spa with a TV in the cabinet. The last 11 numbers on the UDI label should match the serial number of your existing Penner Spa or Penner Reservoir. Please make sure you attach the corresponding UDI label to the correct Penner product. If you have any questions, please don t hesitate to call our office at 1-800-732-0717.
- Quantity
- 21 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401
- 510(k) numbers
- ["K040772"]
- PMA numbers
- not on file
- Product code
- ILJ
- Firm FEI
- 1922538
- Firm city
- Aurora
- Firm state
- NE
- Firm country
- not on file
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