Recall Z-1503-2026— Penner Patient Care, Inc.

Name: FDA recall Z-1503-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-13

Class III · Ongoing

Class III FDA medical device recall by Penner Patient Care, Inc., initiated 2025-08-13. It names one FDA 510(k) clearance: K040772. Product: Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT. Reason: The device does not bear a unique device identifier..

Recalling firm: Penner Patient Care, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2025-08-13
Firm location: Aurora, NE, United States

510(k) clearances named in this recall

1 on FDA's record

K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMPenner Manufacturing, Inc.·cleared 2004-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

Reason for recall

The device does not bear a unique device identifier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.