Data Foundry

Medical device recalls 2018

Symmetry Olsen monopolar cord: — Class II medical device recall Z-1943-2018

Terminated recall by Olsen Medical, reported 2018-06-06. Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

Recall numberZ-1943-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmOlsen Medical, Louisville, KY, United States
Recall initiated2018-05-11
Classified2018-05-25
Reported by FDA2018-06-06
Terminated2019-04-15
Quantity71,890 devices
Reason classessterility, packaging
Model numbers40-2106, 40-2110, 92002

Product

Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.

Reason for recall

Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.

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-1943-2018. 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.