Carefree Surgical Specialties recalls robotic laparoscopy gauze kits due to potential biological contamination and incorrect gauze quantities in sterile packaging. Affected kits may not be sterile, risking infection during surgery.
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Carefree Surgical Specialties is recalling robotic and laparoscopy gauze kits because they may contain biological contaminants that could compromise sterility and have incorrect gauze quantities in the packaging. This could lead to infections or improper surgical procedures if used without proper sterilization.
The gauze kits may contain biological foreign matter that could compromise sterility, increasing infection risk during surgery. Additionally, the kits might have incorrect gauze quantities in the sterile packaging, potentially leading to insufficient materials for procedures.
Surgical teams and hospitals using Carefree Surgical Specialties' robotic laparoscopy gauze kits with model numbers 15508/25 are most at risk. The recall affects kits sold with lot number 1595.
Check for model numbers 15508/25 on the packaging. Kits with lot number 1595 are affected. These gauze kits are used in robotic and laparoscopy surgeries.
Verify the model number (15508/25) and lot number (1595) on the packaging to confirm if the kit is affected.
The recall is due to potential biological contamination that could compromise sterility and incorrect gauze quantities in the sterile packaging.
The official recall notice does not specify a remedy or action steps for affected products.
The recall indicates potential infection risk from biological contamination, but no specific serious injury mechanism is described.
We’ve drafted a message you can send Carefree Surgical Specialties to request your refund or repair — edit it as you like.
Subject: Recall Z-2281-2025 — Carefree Surgical Specialties Carefree Surgical Specialties Hello, I own a Carefree Surgical Specialties that is covered by recall Z-2281-2025 from Carefree Surgical Specialties. 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.
