Recall archive / FDA device enforcement
Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK D... — FDA record Z-2444-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 27, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 49,654 kits total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2444-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution. OUS distribution pending.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 24, 2026
- Recall initiation date
- Apr 27, 2026
- Center classification date
- Jun 12, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.