Data Foundry

Medical device recalls 2022

Destino Twist 14F — Class II medical device recall Z-0646-2022

Completed recall by Oscor Inc., reported 2022-02-23, distributed in PA, TN. There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Recall numberZ-0646-2022
Product typeMedical device
ClassificationClass II
StatusCompleted
Voluntary or mandatedVoluntary
Recalling firmOscor Inc., Palm Harbor, FL, United States
Recall initiated2021-12-22
Classified2022-02-17
Reported by FDA2022-02-23
DistributedPA, TN
Countries outside the USCZ
Quantity549 units
UPC / GTIN / UDI-DI00885672010911, 00885672011123
Lot numbersPQOC13475
Model numbersD141103, DST1405525

Product

Destino Twist 14F (also branded as Guidestar 14F)

Reason for recall

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

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-0646-2022. 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.