FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
- Recall number
- Z-3208-2026
- Recalling firm
- Medline Industries, LP
- Product
- Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
- Status
- Open, Classified
- Initiated
- 2026-07-31
- Posted
- 2026-09-16
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits.
- Quantity
- 459
- Distribution
- US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
- Lot, serial or model codes
- DYNJ58421A UDI-DI 10193489970487 Lot 25HBQ049 DYNJ40734F UDI-DI 10198459162084 Lots 25GBO299 25IBS607
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDE
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28