Medline Industries, LP 2026-05-13 Health serious FDA
Health · FDA · Recall #FDA-Z-2093-2026
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model… Recall
Issued May 13, 2026 · Medline Industries, LP
In May 2026, Medline Industries, LP recalled the See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medline Industries, LP to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medline Industries, LP
- Category
- Health
- Recall date
- May 13, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution.
- Recall number
- FDA-Z-2093-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Medline Industries, LP has 50 recalls in our database, including 8 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.