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Klarity Medical Products LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · May 20, 2026
Last warning letter 2020

Inspections 7

1 OAI

Recalls 1

0 Class I (0%)

Warning letters 1 Latest Jun 8, 2020

510(k) clearances 1 Latest Nov 1, 2013

Klarity Medical Products LLC has 1 FDA recall, 7 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Klarity Medical Products LLC, the most recent on Jun 8, 2020.

What these totals cover: FDA records filed under the name "Klarity Medical Products LLC" and its spelling variant "Klarity Medical Products".

Latest recall: Z-2881-2020 · Class II · Jul 31, 2020
Latest inspection: May 20, 2026 · NAI
Latest 510(k): Nov 1, 2013

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	1	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Klarity Medical Products LLC: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records
2026	1	0	0	0
2025	0	0	0	0
2024	0	0	0	0
2023	1	0	0	0
2022	0	0	0	0
2021	1	0	0	0
2020	1	1	1	1
2019	0	0	0	0
2018	0	0	0	0
2017	0	0	0	0

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.

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Klarity Medical Products LLC FDA Warning Letters

1 warning letter on Jun 8, 2020.

Issued	Subject	Issuing office	Close-out letter
Jun 8, 2020 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent recalls

1 recall record on Jul 31, 2020.

Number	Class	Product	Date
Z-2881-2020	Class II	Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC…	Jul 31, 2020

Recent FDA inspections

7 inspections from Feb 23, 2010 to May 20, 2026.

Date	Site	Product	Classification	FEI
May 20, 2026	Heath, OH	Devices	No Action Indicated (NAI)	3001236129
Feb 16, 2023	Heath, OH	Devices	Voluntary Action Indicated (VAI)	3001236129
Jul 9, 2021	Heath, OH	Devices	Voluntary Action Indicated (VAI)	3001236129
Feb 25, 2020	Heath, OH	Devices	Official Action Indicated (OAI)	3001236129
Nov 8, 2016	Heath, OH	Devices	Voluntary Action Indicated (VAI)	3001236129
Sep 30, 2013	Heath, OH	Devices	Voluntary Action Indicated (VAI)	3001236129
Feb 23, 2010	Heath, OH	Devices	Voluntary Action Indicated (VAI)	3001236129

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Klarity Medical Products LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 8, 2020.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3001236129	Heath, OH	7	May 20, 2026

Recent 510(k) clearances

1 510(k) clearance on Nov 1, 2013.

K-Number	Device	Date
K132124	KLARITY VACUUM BAG, KLARITY MOLD CUSHION	Nov 1, 2013

Klarity Medical Products LLC and the FDA: common questions

Has Klarity Medical Products LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Klarity Medical Products LLC. The most recent is dated Jun 8, 2020.

Has Klarity Medical Products LLC received an FDA Form 483?

FDA has not published a Form 483 for "Klarity Medical Products LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Klarity Medical Products LLC?

The most recent FDA inspection on file ended May 20, 2026 at Heath, OH and was classified NAI. FDA has 7 inspections of Klarity Medical Products LLC on file, 1 of them classified OAI (official action indicated).

Has Klarity Medical Products LLC had an FDA recall?

Yes. Klarity Medical Products LLC has 1 FDA recall on record. The most recent started Jul 31, 2020.

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