What are the full details and dates of the FDA Class II recall for the NeuroMax Cartridge?
Executive summary
The FDA has a recorded Class II device recall entry for the "NeuroMax Cartridge" in its medical device recall database (accessdata.fda.gov), but the publicly provided search snippets do not include the recall narrative, firm name, specific lot, or the initial recall date on the extracts supplied here [1] [2]. Class II recalls indicate potential for temporary or medically reversible adverse health consequences or a remote probability of serious adverse events according to FDA definitions, and the agency’s recall pages explain how such actions are classified and communicated [3] [4].
1. What the public record shows: a database entry exists but key details are missing
The FDA’s Medical Device Recalls database contains an entry titled "Class 2 Device Recall NeuroMax Cartridge," confirming a classified action is recorded in the agency’s system [1] [2]. The accessible search snippet offered here shows the existence and last-update metadata but does not include the recall narrative — for example, the reason for the recall, the manufacturer or distributor, the dates when the recall was initiated and updated, affected lot or catalog numbers, or specific mitigation instructions for healthcare providers or patients [1]. That lack of detailed content in the supplied reporting means the public-facing page likely holds the complete details; they simply were not captured in the excerpts provided to this analysis [2].
2. What “Class II” means for patients and clinicians
Under FDA recall definitions, a Class II designation means the use of or exposure to the recalled device may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote [3]. The FDA’s general guidance to consumers about Class II device/drug recalls indicates that, depending on the manufacturer’s communication, patients may be advised to continue use unless told otherwise, and clinicians should follow the recall letter or firm instructions for evaluation, replacement, or return of affected devices [5] [4]. Those procedural expectations reflect both risk considerations and the practical need to avoid unnecessary disruption of care.
3. Where the full recall narrative and timeline are published
The FDA posts recall communications and, for medical devices, records them in the CDRH recall database; the database entry typically includes the recall initiation date, reason, firm name, description of the product, affected lots and distribution, actions taken, and the recalling firm's press or recall letter [2] [6]. If details are needed beyond the snippet shown here, the FDA’s recall record page for the NeuroMax Cartridge is the authoritative source to retrieve exact dates, the firm’s corrective actions, and any patient or clinician instructions [1] [2].
4. Why the supplied reporting may understate or omit specifics
The search excerpts in the provided reporting emphasize index metadata (page existence and last-update) without the body copy; the FDA’s web archive and recall lists sometimes summarize or redirect to full press releases and recall letters that contain the operative dates and product identifiers [6] [2]. That means summaries or secondary reports that rely on database indexes can inadvertently strip out the most actionable data — an implicit limitation of relying solely on search snippets rather than the primary recall document [2].
5. How to obtain the exact dates and full corrective actions
To obtain the full recall details — the exact date the recall was posted or initiated, the reason (e.g., contamination, labeling, dysfunctional performance), impacted lots and distribution scope, and firm-specific instructions — consult the FDA’s individual recall page for the NeuroMax Cartridge via the Medical Device Recalls database or the FDA Recalls page and archive search tools; those pages host the full recall narrative and the recalling firm’s communications [1] [6] [2]. The FDA also provides broader guidance on recall classes and how firms communicate recalls, which will help interpret the significance of the NeuroMax Cartridge’s Class II designation [3] [4].