ClearanceBrief
Recall Z-1499-2026 ยท ILJ Bath, Hydro-Massage

Penner Patient Care, Inc.

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

DateMar 9, 2026 (initiated Aug 13, 2025)
StatusOpen, Classified
ReasonThe device does not bear a unique device identifier.
Root causeError in labeling
ActionRecall 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. Pleas
Quantity21 units
DistributionUS Nationwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
Penner Manufacturing, Inc., Apr 5, 2004