FDA-Device2026-03-18Class IIIMISBRANDING

Penner Pacific Bathing Spa Model 360020-1P recalled for missing unique device identifier

OTHERNationwide distributionMedical devices

What this means

Penner Patient Care, Inc. is recalling certain Penner Pacific Bathing Spa units (Model 360020-1P) because they do not have a unique device identifier (UDI) as required by federal regulations. This affects 45 units distributed nationwide. No injuries have been reported.

  • Check if your bathing spa serial number matches the recall list (45 specific serial numbers affected).
  • Contact Penner Patient Care, Inc. for instructions on how to obtain a UDI label or replacement.
  • Do not use the device until you have confirmed with the manufacturer whether your unit is affected.
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
45 units
Manufactured in
101 Grant St, N/A, Aurora, NE, United States
Products
Penner Pacific Bathing Spa, Model Numbers 360020-1P

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2026

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