Facility

PRIMUS Sterilizer Company LLC

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

Key facts

2recalls · worst Class II

—inspections in our data

—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)	3030597797
Establishment type	Manufacture Medical Device
Location	110 Tech Dr Sanford, FL, US 32771
Registration status	Active · expires 2026
Parent company	Primus (owner-operator 9005293)
Brand names	three

Activity by year

Recalls (2)

Devices registered here (1)

Sterilizer, Steam
Product code FLE (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6880

Recalls & enforcement

Class IIITerminated2021-10-05
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further te…
Class IITerminated2020-10-09
The product did not receive pre-market approval or clearance.

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. “PRIMUS Sterilizer Company LLC (FEI 3030597797) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030597797-primus-sterilizer-company-llc/

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