Facility

Microspecialties LLC

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

Key facts

1recalls · worst Class II

1inspections · 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)	3002616700
Establishment type	Repack or Relabel Medical Device
Location	430 Smith St Middletown, CT, US 06457
Registration status	Active · expires 2026
Parent company	MICROSPECIALTIES LLC (owner-operator 10053719)
Brand names	PRO EYE SHIELD

Activity by year

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

Devices registered here (1)

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Product code HOY (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.4750

Recalls & enforcement

Class IIOngoing2024-06-05
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.

FDA inspections (1)

OAI2025-02-18
Official 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 Letter2025-05-08
Warning Letter (opens in a new tab) · Middletown Connecticut

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 MICROSPECIALTIES 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. “Microspecialties LLC (FEI 3002616700) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002616700-microspecialties-llc/

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