The Recall Desk

FDA (Devices) recall action 98994

Medline Industries, LP recalled 30 products on 2026-06-24

The FDA (Devices) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.

Products
30
Announced
2026-06-24
Critical
0
Units
15,800,231

Why these products were recalled

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–30 of 30

  • HighFDA (Devices)··2026-06-24

    Medline retina procedure kits contain catheters failing performance specifications

    Medline Retina LAC/USC CDS procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 2,340 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98377
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2026-06-24

    Medline labour delivery and vaginal kits contain substandard catheters

    Medline labour and delivery and vaginal procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 24,388 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIV
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2026-06-24

    Medline urology and gynaecology kits contain catheters failing specifications

    Medline procedure kits including robotic cystectomy, D&C and lithotomy packs are being recalled because sample catheters did not meet performance specifications. 32,438 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2026-06-24

    Medline open heart and cardiac kits contain catheters failing specifications

    Medline open heart and cardiac procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 168,968 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2026-06-24

    Medline Robinson 22 Fr catheter packs fail performance specifications

    Medline CATH 22F Robinson sterile 5-packs are being recalled because representative samples did not meet applicable catheter performance specifications. 1,000 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
    Category
    Distribution
    4 states