Facility

SAFE N SIMPLE LLC

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

Key facts

3recalls · worst Class II

2inspections · worst VAI

—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)	3008374791
Establishment type	Manufacture Medical Device
Location	5827 Terex Clarkston, MI, US 48346
Registration status	Active · expires 2026
Parent company	Safe N Simple LLC (owner-operator 10033201)

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Tape And Bandage, Adhesive
Product code KGX (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5240

Recalls & enforcement

Class IITerminated2018-08-22
The sterilization process used was unqualified.
Class IITerminated2017-12-14
The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
Class IITerminated2012-06-18
The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.

FDA inspections (2)

NAI2023-03-01
No Action Indicated · Compliance: Devices
NAI2018-06-01
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 Safe N Simple 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. “SAFE N SIMPLE LLC (FEI 3008374791) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008374791-safe-n-simple-llc/

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