FDA Medical Device Recalls (openFDA)
Penner Patient Care, Inc.: Penner Pacific Bathing Spa, Model Numbers 860010-1L
- Recall number
- Z-1508-2026
- Recalling firm
- Penner Patient Care, Inc.
- Product
- Penner Pacific Bathing Spa, Model Numbers 860010-1L
- 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
- 26 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 0085007365409; Serial Numbers: 07246737902 10236603401 10226407101 03236488101 03246677601 08226379901 08226385601 12236632601 07226353601 08236572201 04246696501 01256844001 12246811601 06226337201 07236557301 09236582001 02246663101 09246761901 08226369401 08226374601 01246644601 04246691701 08246756001 10236600001 04256958001 04256952001
- 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