Facility

KLARITY MEDICAL PRODUCTS, LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

5inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3001236129
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	600 Industrial Pkwy Heath, OH, US 43056
Registration status	Active · expires 2026
Parent company	KLARITY MEDICAL PRODUCTS, LLC (owner-operator 9031393)
Brand names	Klarity Thermoplastic, Klarity Green, Klarity White, Klarity Blue, BiteLok

Activity by year

Recalls (1)
Inspections (5)
Warning letters (1)

Devices registered here (1)

Accelerator, Linear, Medical
Product code IYE (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

Class IITerminated2020-07-31
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

FDA inspections (5)

VAI2026-05-20
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2023-02-16
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2021-07-09
Voluntary Action Indicated · Compliance: Devices · citations posted
OAI2020-02-25
Official Action Indicated · Compliance: Devices · citations posted
VAI2016-11-08
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2020-06-08
Warning Letter (opens in a new tab) · Heath Ohio

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by KLARITY MEDICAL PRODUCTS, LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “KLARITY MEDICAL PRODUCTS, LLC (FEI 3001236129) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001236129-klarity-medical-products-llc/

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