Medline recalls 158 convenience kits with potential sterility issues due to calibration problems in sterilization equipment. All kits were exposed to validated cycles but may not meet sterility standards.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline is recalling 158 different convenience kits that were sterilized using equipment with calibration issues. This could mean the kits aren't sterile enough for medical use. If you have any of these kits, you should check the model numbers and lot numbers listed in the recall.
The sterilization equipment used to package these kits had calibration issues. This means the kits might not be sterile enough for medical use, but the problem is with the sterilization process, not the kits themselves.
Healthcare workers and medical facilities that use these convenience kits for surgical procedures. The risk is low because the issue is with the sterilization process, not the kits themselves.
Check the model number and lot number on the kit. The recall includes 158 specific model numbers with corresponding lot numbers listed in the detailed record. Examples include CDS820080N (Lot 23IMB818) and DYNJ900602K (Lot 25BDB001).
Look for the model number and lot number on the kit. The recall includes 158 specific model numbers with corresponding lot numbers listed in the detailed record.
The recall states that the kits may not meet sterility standards due to calibration issues in the sterilization equipment, so they should not be used until the recall is addressed.
Check the model number and lot number on the kit. The recall includes 158 specific model numbers with corresponding lot numbers listed in the detailed record.
The recall does not specify a remedy, so you should contact Medline directly to determine the next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2110-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2110-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
