Medline recalls ST or Mayo Hegar Needleholder 6" (OR2500) due to weak seals that may breach sterility, increasing infection risk. Affected units have specific lot numbers and item numbers.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Medline is recalling ST or Mayo Hegar Needleholders with a 6-inch length (model OR2500) because weak seals might cause sterility breaches that aren't easily detected. This could lead to infections if used in medical procedures without proper sterility.
The needleholder's seals may weaken over time, creating gaps that allow contaminants to enter the sterile field. Since users cannot easily detect this breach, infections could occur during surgery without obvious signs.
Healthcare professionals using the needleholder in surgical procedures are most at risk. Patients undergoing surgery with this device could face infection if sterility is compromised.
Check for Medline item number 67870 on the product. Affected units have lot numbers starting with 2023091290 and UDI codes 00653160196894 (single unit) or 30653160196895 (case).
Identify the Medline item number 67870 and lot numbers starting with 2023091290 to confirm if your unit is affected.
The recall states weak seals may cause undetectable sterility breaches, increasing infection risk. Affected units should be checked for recall details.
Look for Medline item number 67870 and lot numbers starting with 2023091290. UDI codes 00653160196894 (single unit) or 30653160196895 (case) also indicate affected units.
The recall does not specify a remedy, so check the product details to confirm if it's affected. If affected, contact Medline for further instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0756-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-0756-2025 from Medline. 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.
