Class III U.S. Food and Drug Administration

Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 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-1507-2026
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
190 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 0085007365408; Serial Numbers: 08216172001 07205587101 09195387501 06216130401 06226336703 03226285001 07205587102 07205587102 10216194401 05205566901 08205620801 08246753903 06226345801 05216107103 08216170401 08195374901 09205629101 02226268801 05216098901 05246710101 04226317301 01226251403 08195367701 02226274601 08195367501 11226430901 10246773202 10246778301 02205500703 12195458301 03226297101 10205654401 10205654402 10246773201 01236457201 10195408001 05216106401 11216217002 06226336702 02256885901 10246776501 01205470801 02205500701 02216027601 09195396901 02236474901 02216042601 06246726801 01205470701 01236457202 02226268802 04216087001 03236497001 02246658801 07205601501 09216184102 10205654302 11216217001 04205552801 08195374801 03205534001 05205553001 05205553002 07205605501 07205605502 07205605503 07205605504 07205605505 02226278501 03236482501 01246639801 01246651201 01246651202 11236614902 08195367801 01226251401 09205628801 06216115102 09216184103 08246752402 11226432201 02256890001 09246763202 09246767901 09246767902 08216167602 04246689601 11246799301 11205673701 12226438801 06216132401 06216132402 07216147101 09216184101 11216212801 09205638801 09236593102 01246654601 01256819701 01256858401 11246799302 07226367202 02246663102 04205552701 01205488401 04246702501 12246803401 04226309009 06246728901 06216130301 09205633201 04216094201 12226445201 08216167601 11205674401 06226337201 09246763201 10205659001 09226400901 09236593101 10205658101 09226387902 02205504901 04205552902 05216101101 05226330401 04246702501 01256858402 03256936501 10205653401 10205654301 01236461401 12236627901 04236504902 12226441901 05226330402 05216107101 10205653402 01216010402 05236517801 02236464701 03246677401 04236504901 07236550501 12195443001 02236478301 11226426301 01205479701 03205534101 01226251402 08236577101 09226387901 07246737901 10246787801 06205578701 06205578702 01226262601 08203185603 08236579201 02205500702 10226420401 08246752401 11216222502 08195368801 10216194402 08236572401 03236492701 07216150101 09226390101 03205517901 03226285002 07216150102 06216130302 10246789501 09226387903 09216176801 08246753901 06216115101 04205552901 11216210801 08195374902 04205552702 08226367703 02205504501 12216230701 08236579202 08216167603 03256906001 04256955501 03256908201
UPC codes
0085007365408

Products covered by this recall

Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1

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.

  • 0085007365408

Model or item number

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

  • 760010-1
  • 770010-1 — UDI-DI

Serial number

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

  • 08216172001 07205587101 09195387501 06216

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 0085007365408; model number 760010-1, 770010-1 — 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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