FDA-Device2026-03-18Class IIIMISBRANDING

Penner Pacific Bathing Spa recalled for missing unique device identifier

OTHERNationwide distributionMedical devices

What this means

Penner Patient Care, Inc. is recalling certain Penner Pacific Bathing Spa units because they do not have the required unique device identifier (UDI) label. This is a regulatory compliance issue. No injuries have been reported.

  • Check if your spa's serial number matches the list provided by the FDA
  • Contact Penner Patient Care, Inc. for instructions on obtaining the missing identifier or a replacement
  • Do not discard the spa until you receive further guidance
The agency's original wording
Hazard

The device does not bear a unique device identifier.

Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
158 units
Manufactured in
101 Grant St, N/A, Aurora, NE, United States
Products
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2026

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