CLASS III ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report

Penner Pacific Bathing Spa recalled by Penner Patient Care

Penner Patient Care is recalling Penner Pacific Bathing Spa, distributed nationwide in the US. The recall was initiated on 13 Aug 2025 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201

Quantity recalled15 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1506-2026
FDA event ID: 98396
Recalling firm: Penner Patient Care, Aurora, NE
Classification: Class III
Status: Ongoing
Recall initiated: 13 Aug 2025
FDA classified: 9 Mar 2026
Reported: 18 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

13 Aug 2025	Recall initiated by company
9 Mar 2026	Classified by FDA	+208 days
18 Mar 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The device does not bear a unique device identifier.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

The device does not bear a unique device identifier.

Which lots are affected?

UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 98396

This product is part of a recall event; the main page for the event is Penner Pacific Bathing Spa recalled by Penner Patient Care.

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide

More recalls from Penner Patient Care

All 10

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS III	Penner Pacific Bathing Spa recalled by Penner Patient Care	Penner Patient Care	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,857

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Major Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide