FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B
- Recall number
- Z-2444-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B
- Status
- Open, Classified
- Initiated
- 2026-04-27
- Posted
- 2026-06-12
- Terminated
- not on file
- Reason
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Root cause
- Process control
- Action
- Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
- Quantity
- 49,654 kits total
- Distribution
- US Nationwide distribution. OUS distribution pending.
- Lot, serial or model codes
- DYNJ58304B UDI-DI 10195327512699 Lot 25LBP470 DYNJ56573B UDI-DI 10193489903669 Lot 25KBK220 DYNJ29135N UDI-DI 10195327674755 Lot 25LMG563 DYNJ65916B UDI-DI 10193489902044 Lots 25KBG852 25LBB895 CDS983672P UDI-DI 10198459149139 Lots 25LBO027 26BBB852 DYNJ21877W UDI-DI 10195327104542 Lot 25JBW040 DYNJ39316D UDI-DI 10198459224447 Lot 25KBH774 DYNJ58354F UDI-DI 10195327515232 Lot 25KBI240 DYNJ0618174N UDI-DI 10195327227340 Lot 25KBC715 DYNJ35761D UDI-DI 10195327565374 Lot 26CBC772 DYNJ0972604A UDI-DI 10889942403905 Lot 25LMF965 CDS983686I UDI-DI 10193489852981 Lot 26ABE755 DYNJ52059D UDI-DI 10195327361785 Lots 25LBQ917 26CBE736 DYNJ43663A UDI-DI 10193489793680 Lot 26CBB662 DYNJ45640B UDI-DI 10193489494983 Lot 25LMJ305
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- 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