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: 0085007365403; Serial Numbers: 11193097601 10216195501 10216195502 12193104901 06226342101 06226342102 06226342105 06226342107 03203148701 01226259601 10226410801 06246724701 10203210401 10203210402 05216113101 11193095401 01203118301 05216107301 05216107302 05216107303 05216107304 05216107305 05216108301 05216108302 06193030201 03203147601 09193066601 03216060801 07193052301 09236591501 02246673801 02192976301 03246682701 01192960801 01192960802 06236535501 08152390701 03216065101 05182864901 01142094001 11121856201 03192998301 01192959801 01226256901 03256938801

Quantity recalled45 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-1502-2026
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 360020-1P

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: 0085007365403; Serial Numbers: 11193097601 10216195501 10216195502 12193104901 06226342101 06226342102 06226342105 06226342107 03203148701 01226259601 10226410801 06246724701 10203210401 10203210402 05216113101 11193095401 01203118301 05216107301 05216107302 05216107303 05216107304 05216107305 05216108301 05216108302 06193030201 03203147601 09193066601 03216060801 07193052301 09236591501 02246673801 02192976301 03246682701 01192960801 01192960802 06236535501 08152390701 03216065101 05182864901 01142094001 11121856201 03192998301 01192959801 01226256901 03256938801

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

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 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide