FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
- Recall number
- Z-1879-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
- Status
- Open, Classified
- Initiated
- 2026-02-27
- Posted
- 2026-04-17
- Terminated
- not on file
- Reason
- Unapproved design changes to the products outside of the 510(k) clearance.
- Root cause
- Component change control
- Action
- On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
- Quantity
- 270,311 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
- Lot, serial or model codes
- DYNJ38587A UDI-DI 10193489754070 (EA) 40193489754071 (CS) LOTS 20BBF696 20EBH917 20FBW435 20HBM667 20JBF107 20KBW292 20LBS930 21EBB195 21FBR610 21GBS936 21GBS940 21JBU912 21KBP999 22ABX182 22EBI922 22GBZ788 22JBL031 23BBN160 DYNJ38587B UDI-DI 10195327397326 (EA) 40195327397327 (CS) LOTS 23DBP789 23FBM124 23HBW639 23JBN841 24ABG236 24CBM867 24FME120 24JMD066 24LME187 DYNJ30078D UDI-DI 10889942138647 (EA) 40889942138648 (CS) LOTS 23CBK546 23FBQ481 23IBQ435 23JBR634 23LBG856 24ABE287 24BBS264 24EBQ336 24GBJ987 24JBO830 DYNJ59108B UDI-DI 10198459138461 (EA) 40198459138462 (CS) LOT 24JBP861 ***Updated 5/20/26 - The following lots were included in the customer communication but not in the FDA submission.*** DYNJ30078D Lots 21EBD861 21IBM130 21IBV938 21IBV939 21IBV940 21LBB809 22ABZ810 22BBV614 22FBL865 22IBE477 22JBH508 22KBJ437 22OBC310 23BBT881 23EBK298; DYNJ38587B Lots 25BMB873; DYNJ59108B Lots 24LBT539
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFG
- 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