FDA-Device2026-09-23Class IIPACKAGING DEFECT

Medline Industries convenience kits recalled for open sterile pouch seals

OTHERNationwide distributionMedical devices

What this means

Medline Industries convenience kits (model numbers DYNJ58421A and DYNJ40734F) may have open seals in their sterile pouch packaging. An open seal can allow bacteria or other contaminants to enter the package, potentially compromising the sterility of the product. If used without detecting the open seal, this could lead to infection or contamination during a medical procedure.

  • Check any Medline convenience kits you have for open or damaged seals before use.
  • Do not use kits with visibly open or compromised seals.
  • Contact Medline Industries or your supplier if you have affected lot numbers (25HBQ049 or 25GBO299 or 25IBS607).
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The agency's original wording
Hazard

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Affected count
459
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3208-2026

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