{"url_path":"/fda/device/recalls/Z-2504-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — 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.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-04","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2504-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":197,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2504-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-04\n**Report date:** 2026-06-24\n\n## Product\nMEDLINE 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.\n\n## Reason\nDuring 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.\n\n## Affected lots\nMedline Product Number/SKU DYNJ53973C:  UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21KME435;  Medline Product Number/SKU DYNJ53973C:  UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMC247;  Medline Product Number/SKU DYNJ53973C:  UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMB678;  Medline Product Number/SKU DYNJ53973C:  UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21IMH919;  Medline Product Number/SKU DYNJ60583C:  UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24CBO389;  Medline Product Number/SKU DYNJ60583C:  UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24ABR872.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI."}