Class III U.S. Food and Drug Administration

Penner Pacific Bathing Spa, Model Numbers 361910-1A recall: The device does not bear a unique device identifier

Recall published 7 months ago

The device does not bear a unique device identifier.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: The device does not bear a unique device identifier.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1504-2026
Published
March 18, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Penner Patient Care, Inc.
Product type
Medical devices
Units affected
158 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
0085007365405

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 0085007365405

Model or item number

On the rating label, the box or the instruction sheet.

  • 361910-1A
  • 361910-XA
  • 361910-2I
  • 361910

Serial number

On the rating plate, often next to the date of manufacture.

  • 07246739501 07216139901 02192979601 11182

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Penner Patient Care, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Penner Patient Care, Inc. — 101 Grant St, Aurora, NE, 68818-3200

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Penner Patient Care, Inc. medical devices recalled?

The device does not bear a unique device identifier. The device does not bear a unique device identifier.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 0085007365405; model number 361910-1A, 361910-XA, 361910-2I. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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