Facility

GSI CORP.

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

Key facts

1recalls · 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)	3002119169
Establishment type	Repack or Relabel Medical Device
Location	1005 Kane Concourse Bay Harbor Islands, FL, US 33154
Registration status	Active · expires 2026
Parent company	GSI CORP. (owner-operator 9034148)

Activity by year

Recalls (1)

Devices registered here (1)

Sunglasses (Non-Prescription Including Photosensitive)
Product code HQY (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.5850

Recalls & enforcement

Class IITerminated2015-12-02
The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer

All facilities operated by GSI CORP.

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. “GSI CORP. (FEI 3002119169) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002119169-gsi-corp/

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