FDA-Device2026-09-23Class IIPACKAGING DEFECT
Medline myringotomy pack recalled for compromised sterile seal
What this means
Medline Industries' myringotomy convenience kits (model MYRINGOTOMY PACK-LF, lot 25FBU754) may have open seals in their sterile pouches. An open seal can allow contamination that may not be visible before use, potentially leading to infection if the kit is used on a patient.
- Check your inventory for lot 25FBU754 (UDI-DI 10198459046551).
- Inspect pouches for signs of open or compromised seals before use.
- Do not use kits with open or suspicious seals.
- Contact Medline Industries for instructions on returning or replacing affected kits.
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
60
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3209-2026More Medline recalls
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