Facility

BUSSE HOSPITAL DISPOSABLES

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

Key facts

2recalls · 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)	2433012
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	75 ARKAY DR. HAUPPAUGE, NY, US 11788
Registration status	Active · expires 2026
Parent company	ROBERT BUSSE & CO., INC. (owner-operator 2417536)
Brand names	Busse Eye Procedure Tray

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Eye Tray
Product code OJK (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.4790

Recalls & enforcement

Class IITerminated2017-06-27
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Class IITerminated2016-11-15
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

FDA inspections (2)

VAI2018-04-13
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-10-19
No 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.

All facilities operated by ROBERT BUSSE & CO., INC.

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. “BUSSE HOSPITAL DISPOSABLES (FEI 2433012) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2433012-busse-hospital-disposables/

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