Class III U.S. Food and Drug Administration

Penner Pacific Bathing Spa, Model Numbers 360010-2WT 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-1500-2026
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
643 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 0085007365401; Serial Numbers: 12193105601 09246762101 09246762102 07203174301 07205587001 12236633201 12236633202 09216175802 09216175801 05226320101 05216099201 05216099202 10216200701 01203114101 10193088201 10193088202 05205560701 05205559901 07216148001 07216148002 02226267201 02226267202 06246721701 06246721702 05236523001 05236523002 05236523003 03216064601 03216064602 09185135701 09185135702 11246790502 11246790501 04236501905 04236501902 04236501901 04236501904 07226354201 01236448201 01236448202 01236448203 01236448204 01236448205 01236448206 01236448207 01236448208 08142214601 08236570201 05226328502 05226328501 05226328504 05226328505 11195429001 11195429101 09246761301 09246761302 08185103701 01226253101 08195355001 09205628901 09205629001 08246753101 08246753104 08246753105 08246753106 08246753102 08246753103 02236477101 10182928001 10185152601 10236608401 10236608402 09195378101 09195378001 09195378301 09195378201 11195442101 11195442201 06246726708 06246726707 06246726701 06246726702 06246726703 06246726704 10236606001 10236606002 12195444301 10195404401 10205653901 06226349401 06226349402 12246806501 12246806502 05236519001 05236519002 05236519003 05236519004 02226264002 02226264001 05195290601 05195290701 01216023801 06226349201 05193021201 02226266401 12236630001 03246687001 03246687002 03246687003 03246687004 03246687005 03246687006 03246687007 03246687008 03246687009 10246779601 10246779602 11195437901 11195438001 05205560601 10236605801 10236605802 07194096301 07194096401 02246674001 02246674002 05246711101 04246691101 04246692001 04246691102 04246692002 07216151301 07216151302 04193001201 02195237001 07205596501 07205596601 06226351201 06226351202 08236570403 08236570404 08236570401 08236570402 01226260701 01226260702 02246660901 02246660902 02246660903 02246660904 02246660905 02246660906 02246661001 02246661002 02246661003 02246661004 02246661005 02246661006 06236537501 08185108801 08185108802 08185108901 08185108902 06205573101 06205573201 01226258201 04143643701 02226263801 10205222202 10205222301 01256822501 01256822502 01256822503 01256822504 08185098901 10216199401 10216199402 08193059901 10195399401 10195399501 10216202101 10216202102 02236476302 02236476201 06205580701 06205580702 06205580601 06205580602 02226274801 03226299501 05205567001 03246687504 03246687501 03246687502 03246687505 01205477401 01205477402 01205477403 11205683001 11205683101 06195324701 09226387601 10195408101 10195408201 02236464201 12185183501 12185183601 09226397101 09226397102 04246698801 02226271301 02226271302 03226283201 03226283202 11193094601 11195427401 02246672002 02246672001 04236504701 02205504801 10246776201 10246776202 06246727501 06246727502 10246776203 10246776204 07195338101 07195338102 07195338201 07195338202 07195338301 07195338302 07195338401 07195338402 07246743101 10246780301 10246780302 04195279101 02192973401 05205553901 05205554001 05195296301 05193020001 09226386401 02205499501 02205499601 09205631501 09205631601 05216102601 06216120601 01226249601 04195281001 04195281101 01256821601 01256821602 04236503601 04236503602 04226311501 04226311502 12236630701 12236630702 07246742101 04246689802 03226286001 03226286002 03226286003 03226286004 10246788801 10246788802 03040570501 08195369001 08195369101 11226431101 11226431102 11226431103 11226431104 11226431105 11226431106 06246720301 10193078501 11193091301 03192999001 03226289802 03226289801 11195423001 02195222201 04195277701 02195222302 06195320201 01246656901 01246656902 01226252301 01226252302 04226310001 04226310002 04226310003 04226310004 04226310005 04226310006 09226395103 09226395104 09226395102 09226395101 08246758701 08246758702 08236566001 08236566002 06236541703 06236541702 06236541704 06236541701 05246709101 05246709102 08236573801 08236573802 08236573803 08236573804 08236573701 08236573702 08236573703 01192956501 01256823302 01256823307 01256823301 01256823304 01256823305 12246806101 01226253401 01226253402 11195431901 11195431902 …
UPC codes
0085007365401

Products covered by this recall

Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

Check your product

The notice names 9 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.

  • 0085007365401

Model or item number

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

  • 360010-2WT
  • 360010-1
  • 370000-1W
  • 360010-1WT
  • 362010

Serial number

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

  • 12193105601 09246762101 09246762102 07203

Package size

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

  • 1 L
  • 2 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. 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.

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 0085007365401; model number 360010-2WT, 360010-1, 370000-1W. 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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