Oscor recalls Destino Twist 14F (Guidestar 14F) models with possible hub separation risk. Affected units include specific model numbers and lots. No remedy stated in recall.
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Oscor is recalling Destino Twist 14F (also called Guidestar 14F) devices due to a potential separation between the threaded hub and cap at one end. This could lead to the device becoming unstable or malfunctioning, though the recall does not specify serious injury risks or a fix.
The threaded hub and cap at the proximal end of the device could separate, potentially causing the device to become unstable or malfunction. This separation might affect the device's proper function but does not indicate a risk of serious injury in normal use.
Users of Destino Twist 14F or Guidestar 14F devices with specific model numbers and production lots listed in the recall. People using these devices for medical purposes may be at slightly higher risk if the hub separates.
Check for model numbers DST1405525 (Destino Twist 14F) or D141103 (Guidestar 14F) with specific lots listed in the recall. The recall includes detailed UDI codes for each lot.
Identify your device's model number and lot code from the recall list to confirm if it is affected.
The recall does not state any remedy or fix for this issue.
Check if your device has model number DST1405525 (Destino Twist 14F) or D141103 (Guidestar 14F) with one of the specific lots listed in the recall.
The recall does not specify that users should stop using the device; it only lists affected models and lots.
We’ve drafted a message you can send Oscor to request your refund or repair — edit it as you like.
Subject: Recall Z-0646-2022 — Oscor Oscor Hello, I own a Oscor that is covered by recall Z-0646-2022 from Oscor. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.