FDA recall Z-1500-2026

Penner Patient Care, Inc. · Class III · device

Product

Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

Reason for recall

The device does not bear a unique device identifier.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-08-13
Report date
2026-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aurora, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1500-2026