FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline D and C Pack and catheter kits recalled for connector detachment and dimensional defects

OTHERNationwide distribution

Medline medical procedure kits recalled for catheter defects

Medline identified that certain D and C Pack and catheter kits did not meet quality specifications. Issues found include surface irregularities on catheters, connectors that detached prematurely from the catheter funnel, and catheters with incorrect outer diameter. The affected kits were distributed worldwide.

  • Check if your facility has the affected kit numbers DYNJ53973C or DYNJ60583C
  • Do not use affected kits; contact Medline with your lot number for instructions on return or replacement
  • Review the lot numbers listed in the recall notice to confirm whether your stock is affected
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
168 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2504-2026

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