Facility

F & L MEDICAL PRODUCTS LLC

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

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

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

FDA Establishment Identifier (FEI)	2529126
Establishment type	Manufacture Medical Device
Location	1129 Industrial Park Rd Ste 3 Vandergrift, PA, US 15690
Registration status	Active · expires 2026
Parent company	F & L MEDICAL PRODUCTS LLC (owner-operator 2529126)
Brand names	ATTENURAD CT RADIO

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Shield, Protective, Personnel
Product code KPY (opens in a new tab) · Class I · Radiology · 21 CFR 892.6500

Recalls & enforcement

Class IIOngoing2023-05-04
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
Class IITerminated2020-01-20
There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

FDA inspections (1)

NAI2018-04-05
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

All facilities operated by F & L 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. “F & L MEDICAL PRODUCTS LLC (FEI 2529126) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2529126-f-l-medical-products-llc/

Not open yet

Alerts for F & L MEDICAL PRODUCTS LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.