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
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-1504-2026
- 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 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Penner Pacific Bathing Spa recalled?
Yes. Penner Patient Care recalled Penner Pacific Bathing Spa on 13 Aug 2025. The recall is Class III and its status is Ongoing. Recall number Z-1504-2026.
Why was it recalled?
The device does not bear a unique device identifier.
Which lots are affected?
UDI-DI: 0085007365405; Serial Numbers: 07246739501 07216139901 02192979601 11182940903 12193105501 09185135601 09185135602 11246797901 05236523801 08236568901 08236568902 11216211801 10226408001 10226408002 06193032901 04246699301 04246699302 06226346001 03192988001 05193026301 08182896501 08182896502 08182896503 08182896504 05216110201 06246732101 06246732102 05193020401 11216226901 09246768801 11203215901 09182915601 04193013701 01203113401 10246774001 09193066801 07226353001 07226359101 01256834801 08236567401 11236611101 11226430001 02246665701 10182930801 03246680001 01192960601 03236486401 06236533901 05236526702 09216179201 10193089801 06236532901 06236532902 06236532903 08182902101 03192995801 03192995802 09193067401 07205595301 04216084401 04193002001 04193002002 11216213101 11182939701 09193074901 09193074902 01236449501 01236449502 03192987401 03203142901 03203142902 02192981501 02192981502 05226324701 03226296101 09203198701 04246693301 07226356501 04216092701 04236503401 11236613601 11236613602 02226270303 04226309007 04226309008 01246648301 01246648302 06081036001 03203140001 03203140002 03205525101 07226356201 03216055401 04193000001 11203216801 11203216802 07193044101 01203116101 01203116102 01203116103 05246713401 05246713402 07246738901 07193050501 10246777701 12226443001 11226427301 05216098101 11226433501 09226401501 08216173101 08216173102 05203162501 06226339001 06226339002 05193018601 04216081201 11182933201 11182933202 11236611301 09236584601 09236584602 07193042101 12182947701 01256823701 10226421501 01256838101 04216081901 10226417301 09193071201 02246672301 07205596301 12236524501 11193098801 03216073501 01256852601 10246788401 02226266601 03192998901 12182946201 10236598101 05193023401 05193023402 01226261601 02203131401 03192987901 03192987902 03192987903 02246671801 04246704401 06203167601 07246745601 07216151101 10195414701 01236457001 06193029401 06193029402 04256970101
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Penner Patient Care
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Penner Pacific Bathing Spa recalled by Penner Patient Care | Penner Patient Care | Device Malfunction | Nationwide |
| Device | CLASS III | Penner Pacific Bathing Spa recalled by Penner Patient Care | Penner Patient Care | Device Malfunction | Nationwide |
| Device | CLASS III | Penner Pacific Bathing Spa recalled by Penner Patient Care | Penner Patient Care | Device Malfunction | Nationwide |
| Device | CLASS III | Penner Pacific Bathing Spa recalled by Penner Patient Care | Penner Patient Care | Device Malfunction | Nationwide |
| Device | CLASS III | Penner Pacific Bathing Spa recalled by Penner Patient Care | Penner Patient Care | Device Malfunction | Nationwide |
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