Have any regulatory agencies or watchdogs issued warnings or recalls about NeuroMax?
Executive summary
A U.S. Food and Drug Administration record shows a formal recall for a product labelled “NeuroMax Cartridge,” a Class II device recall listed on the FDA medical device recall database [1]. Other publicly available watchdog traces in the provided reporting include consumer-facing warnings about products named “NeuroMAX” on Drugs.com and a Better Business Bureau profile with complaints, but the definitive regulatory action in these sources is the FDA recall entry [2] [3] [1].
1. FDA’s recall entry: what the record actually says
The FDA’s device recall database contains a specific entry titled “Class 2 Device Recall NeuroMax Cartridge,” which is the clearest regulatory action about any product named NeuroMax in the supplied reporting [1]. That listing is recorded in the FDA’s public recall infrastructure for medical devices — the agency keeps such recalls on searchable pages and archives them for several years [4] [5]. The recall entry itself is the primary piece of documentary evidence that a regulatory agency has acted with respect to a NeuroMax-branded cartridge [1].
2. What a Class II device recall implies and the agency framework
A Class II recall classification indicates that the agency or reporting party believes the device may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote; this classification and the recall process sit inside FDA postmarket rules for medical devices and recall management [6]. The FDA publishes guidance and maintains pages explaining recalls, corrections and removals for devices and runs a Medical Device Safety and Recalls portal for the most serious notices and early alerts — the NeuroMax Cartridge entry appears within that broader recall architecture [6] [7].
3. Other watchdog or consumer-facing signals in reporting: complaints and product information
Separate from the FDA record, consumer-health sites and business watchdogs show related activity: Drugs.com carries a NeuroMAX monograph with warnings about side effects and usage guidance for a product described as methyl salicylate, reflecting consumer-safety guidance rather than a regulatory recall action [2]. The Better Business Bureau maintains a profile for “NeuroMax Brain US” with customer reviews and complaints, noting the company is not BBB-accredited — this indicates consumer concern and complaints exist in the marketplace but is not equivalent to a regulatory recall [3].
4. Enforcement, retail compliance and practical implications
Even when a recall is posted, prior reporting shows recalled products can linger on shelves and that enforcement and retailer compliance can be imperfect, a dynamic regulators and consumer advocates have repeatedly flagged [8]. That wider context matters for patients and purchasers: an FDA recall entry signals formal action and public notice, but real-world removal from distribution channels can be uneven, as past recall coverage documents [8]. The provided sources do not include follow-up enforcement letters or state-level actions specific to the NeuroMax listing beyond the FDA database entry [1] [8].
5. What the record does not show and limits of available reporting
Within the documents supplied there is no evidence of other federal agencies (for example, the Consumer Product Safety Commission) or international watchdogs issuing separate recalls or warnings about NeuroMax; the record available here centers on the FDA device recall database entry and consumer-facing sites [1] [2] [3]. The reporting also does not include the recall notice’s full text, scope of affected lots, company statements, or adverse event summaries — those details would be necessary to assess the scale, rationale and downstream responses to the recall and are not present in the supplied snippets [1] [6].
6. Bottom line: direct answer
Yes — the supplied reporting shows a formal FDA recall entry for a “NeuroMax Cartridge” listed as a Class II device recall in the agency’s recall database [1], and the FDA’s recall infrastructure and device-recall rules provide the regulatory framework for that action [6] [7]. Other watchdog-like signals in these sources are consumer-information and complaint records (Drugs.com and BBB) rather than additional formal regulatory recalls or warnings [2] [3]. The reporting here does not document additional agency actions, broader enforcement results, or detailed recall scope beyond the FDA entry, which limits a fuller assessment without consulting the full recall notice or subsequent enforcement records [1] [8].