Data Foundry

Medical device recalls 2020

StimQ Peripheral Nerve Stimulator System — Class II medical device recall Z-2928-2020

Ongoing recall by Stimwave Technologies Inc, reported 2020-09-09, distributed nationwide. The product contains a non-functional component not referenced in product labeling.

Recall numberZ-2928-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmStimwave Technologies Inc, Pompano Beach, FL, United States
Recall initiated2020-07-15
Classified2020-09-02
Reported by FDA2020-09-09
DistributedNationwide (US)
Countries outside the USAR, BE, CH, CZ, DE, ES, GB, IL, IR, IT, NL, SK, ZA
Quantity2,444 units
Reason classeslabeling
Serial numbers2.STQ4-RCV-A0, 201173-1, 201173-10, 201173-11, 201173-12, 201173-13, 201173-14, 201173-15, 201173-16, 201173-17, 201173-18, 201173-19, 201173-2, 201173-20, 201173-21, 201173-22, 201173-23, 201173-24, 201173-25, 201173-26, 201173-27, 201173-28, 201173-29, 201173-3, 201173-30 and 475 more
Model numbers2.STQ4-RCV-A0EU, STQ4-RCV-A0US

Product

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Reason for recall

The product contains a non-functional component not referenced in product labeling.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2928-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.