Z-3208-2026 Class II Ongoing
FDA device recall Z-3208-2026 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: 459.
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
- 459
Product Description
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
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
DYNJ58421A UDI-DI 10193489970487 Lot 25HBQ049 DYNJ40734F UDI-DI 10198459162084 Lots 25GBO299 25IBS607