Recall Z-1504-2026— Penner Patient Care, Inc.

Name: FDA recall Z-1504-2026
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 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X. 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 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

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.