FDA Device recall Z-2504-2026

MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C

FDA Device
Class II
ongoing
Published 2026-06-24

On 2026-06-24 the FDA classified a Class II recall of MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C by Medline Industries, citing during an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfa….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2504-2026
Classification	Class II
Status	ongoing
Initiated	2026-05-04
Published	2026-06-24
Last updated	2026-09-13 11:58 UTC
Company	Medline Industries
Distribution	US

Product

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.

Reason

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.

Identifiers

code_info	Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21KME435; Medl… 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.

code_info

Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21KME435; Medl…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2504-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.