Class III U.S. Food and Drug Administration

Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 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

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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-1505-2026
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
25 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 0085007365406; Serial Numbers: 11185169701 01205459101 09236589001 08226376601 05236519007 07154096101 09185123501 09205645001 06216123501 06216123502 06216123503 04246695301 05205559701 05226325001 05226333501 03216074601 03216074602 03216074603 03216074604 04195277301 04216084201 05246707001 06195314201 03256918201 03256945401
UPC codes
0085007365406

Products covered by this recall

Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

Check your product

The notice names 5 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.

  • 0085007365406

Model or item number

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

  • 390010-1
  • 390010-X
  • 390010-2 — UDI-DI

Serial number

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

  • 11185169701 01205459101 09236589001 08226

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. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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 0085007365406; model number 390010-1, 390010-X, 390010-2 — UDI-DI. 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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