Severity
Moderate
FDA Devices recall · Reported July 2, 2025
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Jolife Ab recalled LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing externa… - a moderate-severity action.
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing externa… was recalled by Jolife Ab in July 2, 2025. Reason: Due to demonstration units of chest compression system being provided to a customer which may potentially be …. Check the official notice for the remedy. Verify recall #Z-1998-2025 with the FDA Devices before acting.
The recall
Jolife Ab issued this moderate-severity FDA Devices recall-Due to demonstration units of chest compression system being provided to a customer which may potentially be ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1998-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1998-2025) was formally reported on July 2, 2025, with the manufacturer initiating the action on May 21, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Jolife Ab is listed as the recalling firm, operating out of Lund. Federal records list the affected scope as 5 units.
The documented reason for this recall is: Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of IN, MI, OH and TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
5 units
Related Recalls
6
3 from same agency
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1998-2025 |
| Date reported | July 2, 2025 |
| Date initiated | May 21, 2025 |
| Recalling firm | Jolife Ab |
| Firm location | Lund |
| Affected scope | 5 units |
| Distribution | U.S. Nationwide distribution in the states of IN, MI, OH and TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 2, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.