Facility

CRITICARE TECHNOLOGIES, INC.

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

Key facts

1recalls · worst Class II

5inspections · worst OAI

2warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012238587
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	333 Strawberry Field Rd Warwick, RI, US 02886
Registration status	Active · expires 2026
Parent company	Criticare Technologies, Inc. (owner-operator 10051461)
Brand names	eVision

Activity by year

Recalls (1)
Inspections (5)
Warning letters (2)

Devices registered here (2)

Monitor, St Segment With Alarm
Product code MLD (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Product code MHX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025

Recalls & enforcement

Class IIOngoing2026-05-06
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

FDA inspections (5)

OAI2025-10-28
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2024-05-10
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-10-29
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-06-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2017-03-29
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 (2)

Warning Letter2024-07-12
Warning Letter (opens in a new tab) · Warwick Rhode Island
Warning Letter2017-04-21
Warning Letter (opens in a new tab) · Warwick Rhode Island

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 Criticare Technologies, 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. “CRITICARE TECHNOLOGIES, INC. (FEI 3012238587) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012238587-criticare-technologies-inc/

Not open yet

Alerts for CRITICARE TECHNOLOGIES, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.