Facility

BELMONT MEDICAL TECHNOLOGIES

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

Key facts

6recalls · 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)	1219702
Establishment type	Manufacture Medical Device
Location	780 Boston Rd BILLERICA, MA, US 01821
Registration status	Active · expires 2026
Parent company	BELMONT INSTRUMENT LLC. (owner-operator 1219702)
Brand names	Buddy Disposable Set, 24 sets per box; Buddy Disposable Set, One piece; Buddy Disposable Set, 6 X Box 24=144; Buddy Lite Blood/Fluid Warmer

Activity by year

Recalls (6)

Devices registered here (1)

Warmer, Blood, Non-Electromagnetic Radiation
Product code BSB (opens in a new tab) · Class II · Hematology · 21 CFR 864.9205

Recalls & enforcement

Class IIOngoing2025-05-13
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. …
Class IIOngoing2025-03-31
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Class IIOngoing2025-03-31
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Class IIOngoing2025-01-02
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Class IIOngoing2021-07-20
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has rece…
Class IITerminated2012-09-25
Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.

All facilities operated by BELMONT INSTRUMENT 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. “BELMONT MEDICAL TECHNOLOGIES (FEI 1219702) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1219702-belmont-medical-technologies/

Not open yet

Alerts for BELMONT MEDICAL TECHNOLOGIES

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.