Turncare, Inc

FDA Regulatory Profile

Turncare, Inc has 2 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

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

Latest recall
Z-1967-2025 · Class II · Nov 1, 2023
Latest inspection
Dec 11, 2024 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls2Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Turncare, Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Turncare, Inc: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202310020
202200000
202100000
202000000
201900000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

2 recall records from Aug 10, 2023 to Nov 1, 2023.

NumberClassProductDate
Z-1967-2025Class IIBrand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number…Nov 1, 2023
Z-1968-2025Class IIBrand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number…Aug 10, 2023

Recent FDA inspections

2 inspections from Jun 26, 2023 to Dec 11, 2024.

DateSiteProductClassificationFEI
Dec 11, 2024Pompton Plains, NJDevicesNo Action Indicated (NAI)3013682457
Jun 26, 2023Pompton Plains, NJDevicesVoluntary Action Indicated (VAI)3013682457
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 3013682457Pompton Plains, NJ2Dec 11, 2024

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