Contract Medical International recalls Fortress Introducer Sheath System units with incorrect pouch labels that may list 4F instead of 6F version. Affected units have model 386594 and lot 800989. Contact for remedy.
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
Contract Medical International is recalling Fortress Introducer Sheath System products that may have incorrect pouch labels listing the 4F version instead of the 6F version. This could lead to using the wrong size device, which might not fit properly during medical procedures.
The pouch label may incorrectly list the reference number and unique device identifier for the 4F version instead of the 6F version. This could result in using a smaller device than intended, potentially causing improper fit during medical procedures.
Healthcare professionals using the Fortress Introducer Sheath System for medical procedures are most at risk if they use the recalled units with incorrect labels.
Check for model number 386594 and lot number 800989 on the product. The pouch label should list the 6F version, not the 4F version.
Look for the model number 386594 and lot number 800989 on the product. Verify the pouch label lists the 6F version, not the 4F version.
The model number is 386594.
Lot number 800989 is affected.
Check the pouch label for the model number 386594 and lot number 800989. If it lists the 4F version instead of the 6F version, it is recalled.
We’ve drafted a message you can send Fortress to request your refund or repair — edit it as you like.
Subject: Recall Z-2532-2025 — Fortress Fortress Hello, I own a Fortress that is covered by recall Z-2532-2025 from Fortress. 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.
