Facility

DIVERSATEK HEALTHCARE INC

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

Key facts

2recalls · worst Class II

2inspections · worst NAI

—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)	2183446
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	102 EAST KEEFE AVE. Milwaukee, WI, US 53212
Registration status	Active · expires 2026
Parent company	DIVERSATEK HEALTHCARE INC (owner-operator 2183446)

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (2)

Endoscope Channel Accessory
Product code ODC (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Endoscopic Irrigation/Suction System
Product code OCX (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IIOngoing2026-03-18
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Class IITerminated2021-10-29
M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.

FDA inspections (2)

NAI2022-08-05
No Action Indicated · Compliance: Devices
NAI2016-06-29
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.

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. “DIVERSATEK HEALTHCARE INC (FEI 2183446) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2183446-diversatek-healthcare-inc/

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