Class III U.S. Food and Drug Administration

Penner Pacific Bathing Spa, Model Numbers 560010-2L 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

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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-1506-2026
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
15 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201
UPC codes
0085007365407

Products covered by this recall

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

Check your product

The notice names 8 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.

  • 0085007365407

Model or item number

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

  • 560010-2L
  • 560010-XL
  • 560010-1L
  • 560010-XL — UDI-DI

Serial number

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

  • 11154213601 10205645901 10205645902 04226

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 L
  • 1 L

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. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  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.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

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 0085007365407; model number 560010-2L, 560010-XL, 560010-1L. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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