Official recall notice
FDA DeviceClass IINotable
FDA Recall: Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
- Recall date
- 2026-09-23
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
DYNJ58421A UDI-DI 10193489970487 Lot 25HBQ049 DYNJ40734F UDI-DI 10198459162084 Lots 25GBO299 25IBS607