Facility

DEFIBTECH LLC

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

Key facts

6recalls · worst Class I

—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)	3026976873
Establishment type	Manufacture Medical Device
Location	21 N Branford, CT, US 06471
Registration status	Active · expires 2026
Parent company	DEFIBTECH, LLC (owner-operator 9048526)
Brand names	Lifeline View Auto DDU-2200 Fully-Automatic AED; Lifeline PRO DDU-2400 Semi-Automatic AED; DBP-2800 7-year non-rechargeable battery pack; DDP-2001 Adult Defibrillation Pads; Lifeline View DDU-2300 Semi-Automatic AED; Lifeline Auto DDU-120 Fully-Automatic AED; Lifeline DDU-100 Semi-Automatic AED; DBP-1400 5-year non-rechargeable battery pack; Lifeline ECG DDU-2450 Semi-Automatic AED; DBP-2013 4-year non-rechargeable TSO battery; DDP-2002 Pediatric Defibrillation Pads; DBP-2003 4-year non-rechargeable battery pack

Activity by year

Recalls (6)

Devices registered here (1)

Automated External Defibrillators (Non-Wearable)
Product code MKJ (opens in a new tab) · Class III · Cardiovascular · 21 CFR 870.5310

Recalls & enforcement

Class IIOngoing2025-03-18
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French…
Class IIOngoing2025-03-18
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French…
Class IIOngoing2024-10-14
Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are wi…
Class IOngoing2024-07-12
Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.
Class IIOngoing2023-02-14
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Class IITerminated2020-04-27
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.

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. “DEFIBTECH LLC (FEI 3026976873) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3026976873-defibtech-llc/

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