Penner Patient Care, Inc.

FDA Regulatory Profile

Penner Patient Care, Inc. has 10 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Penner Patient Care, Inc." and its spelling variant "Penner Patient Care".

Latest recall
Z-1503-2026 · Class III · Aug 13, 2025
Latest inspection
Feb 11, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls10Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent recalls

10 recall records on Aug 13, 2025.

NumberClassProductDate
Z-1503-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC…Aug 13, 2025
Z-1502-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360020-1PAug 13, 2025
Z-1508-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 860010-1LAug 13, 2025
Z-1507-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1Aug 13, 2025
Z-1499-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-XAug 13, 2025
Z-1504-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A…Aug 13, 2025
Z-1505-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2Aug 13, 2025
Z-1501-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360020-1EPAug 13, 2025
Z-1500-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1…Aug 13, 2025
Z-1506-2026Class IIIPenner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XLAug 13, 2025

Recent FDA inspections

4 inspections from Apr 1, 2010 to Feb 11, 2025.

DateSiteProductClassificationFEI
Feb 11, 2025Aurora, NEDevicesVoluntary Action Indicated (VAI)1922538
Jun 21, 2016Aurora, NEDevicesVoluntary Action Indicated (VAI)1922538
Jul 10, 2014Aurora, NEDevicesVoluntary Action Indicated (VAI)1922538
Apr 1, 2010Aurora, NEDevicesNo Action Indicated (NAI)1922538
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1922538Aurora, NE4Feb 11, 2025

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.