Device recall

MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A

FDA recall source

Recall number

Z-0273-2027

Event id

99960

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Oct 28, 2026

Posted

Oct 22, 2026

Initiated

Sep 9, 2026

Center classification date

Oct 22, 2026

Product code

PUI

Device type

Drape, Surgical, Exempt

Reason

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Root cause

Under Investigation by firm

Quantity

222 units

Code info

UDI/DI 10889942754496 (each) 40889942754497 (case), Lot numbers: 26FBV563, 26ABH473

Distribution

Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States