Class III U.S. Food and Drug Administration

Penner Pacific Bathing Spa, Model Numbers 860010-1L 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-1508-2026
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
26 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 0085007365409; Serial Numbers: 07246737902 10236603401 10226407101 03236488101 03246677601 08226379901 08226385601 12236632601 07226353601 08236572201 04246696501 01256844001 12246811601 06226337201 07236557301 09236582001 02246663101 09246761901 08226369401 08226374601 01246644601 04246691701 08246756001 10236600001 04256958001 04256952001
UPC codes
0085007365409

Products covered by this recall

Penner Pacific Bathing Spa, Model Numbers 860010-1L

Check your product

The notice names 4 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.

  • 0085007365409

Model or item number

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

  • 860010-1L — UDI-DI

Serial number

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

  • 07246737902 10236603401 10226407101 03236

Package size

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

  • 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. — 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. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

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 0085007365409; model number 860010-1L — 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?

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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