FDA Device recall Z-2487-2026

MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall…

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 CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall… 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-2487-2026
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 CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

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 Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline… Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; M

code_info

Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline…

Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; M

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-2487-2026%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.