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FDAClass II · Medical device · Recalled June 24, 2026
MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP
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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2504-2026
- Brand
- Medline Industries
- Classification
- Class II
- Units affected
- 168 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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.
Affected products
Companies & origin
- Recalling firm location
- Northfield, IL, United States
- Firm address
- 3 Lakes Dr, 60093-2753
Identifying details (verbatim from the notice)
- Product codes / lots
- Medline 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Firm notified the public via
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- FDA event ID
- 98994
- Recall initiated
- May 4, 2026
- FDA classified
- June 17, 2026
- FDA report date
- June 24, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 2:00 AM UTC.
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