Z-3209-2026 Class II Ongoing
FDA device recall Z-3209-2026 was initiated by Medline Industries, LP on July 31, 2026 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 60.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 31, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60
Product Description
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Code Information
UDI-DI 10198459046551 Lot 25FBU754