Defibtech, LLC
Complete recall history across all FDA and CPSC categories — 14 total recalls
Defibtech, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (14)
FDA medical device enforcement actions by Defibtech, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/... | It was noticed there was no Italian translation included for the AED. Article... | Class II |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article... | Class II |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (... | It was noticed there was no Italian translation included for the AED. Article... | Class II |
| Mar 18, 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D... | It was noticed there was no Italian translation included for the AED. Article... | Class II |
| Mar 18, 2025 | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item nu... | It was noticed there was no Italian translation included for the AED. Article... | Class II |
| Oct 14, 2024 | Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: L... | Within the Irish Market, that a Field Safety Notice is being issued due to a ... | Class II |
| Oct 14, 2024 | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline... | Within the Irish Market, a Field Safety Notice is being issued due to a selec... | Class II |
| Oct 14, 2024 | Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: ... | Within the Irish Market, that a Field Safety Notice is being issued due to a ... | Class II |
| Oct 14, 2024 | Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifel... | Within the Irish Market, that a Field Safety Notice is being issued due to a ... | Class II |
| Jul 12, 2024 | RMU-2000 Automated Chest Compression Device | Problem in the device's motor may cause the device to stop compressions. This... | Class I |
| Feb 14, 2023 | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on ... | A component of a sub-assembly used in the affected AEDs had not undergone du... | Class II |
| Apr 27, 2020 | DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated Extern... | A component issue may cause the AED to abort a shock delivery or reset unexpe... | Class II |
| Apr 27, 2020 | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A... | A component issue may cause the AED to abort a shock delivery or reset unexpe... | Class II |
| Apr 27, 2020 | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN ... | A component issue may cause the AED to abort a shock delivery or reset unexpe... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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