Device recall

MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D; 3) OB/GYN, Medline Kit Number/SKU DYNJ911652.

FDA recall source

Recall number: Z-0276-2027
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: 2229 kits
Code info: Medline Kit Number/SKU DYNJ16127N, UDI/DI 10198459449826 (each) 40198459449827 (case), Lot Number 26FBB857; Medline Kit Number/SKU DYNJ16127N, UDI/DI 10198459449826 (each) 40198459449827 (case), Lot Number 26EBA908; Medline Kit Number/SKU DYNJ16127N, UDI/DI 10198459449826 (each) 40198459449827 (case), Lot Number 26CBV797; Medline Kit Number/SKU DYNJ16127N, UDI/DI 10198459449826 (each) 40198459449827 (case), Lot Number 26ABM708; Medline Kit Number/SKU DYNJ16127N, UDI/DI 10198459449826 (each) 40198459449827 (case), Lot Number 25KBQ582; Medline Kit Number/SKU DYNJ27206D, UDI/DI 10198459353611 (each) 40198459353612 (case), Lot Number 26GBV395; Medline Kit Number/SKU DYNJ27206D, UDI/DI 10198459353611 (each) 40198459353612 (case), Lot Number 26FBO061; Medline Kit Number/SKU DYNJ27206D, UDI/DI 10198459353611 (each) 40198459353612 (case), Lot Number 26DBF331; Medline Kit Number/SKU DYNJ27206D, UDI/DI 10198459353611 (each) 40198459353612 (case), Lot Number 26BBT983; Medline Kit Number/SKU DYNJ27206D, UDI/DI 10198459353611 (each) 40198459353612 (case), Lot Number 25LBJ546; Medline Kit Number/SKU DYNJ27206D, UDI/DI 10198459353611 (each) 40198459353612 (case), Lot Number 25KBK623; Medline Kit Number/SKU DYNJ911652, UDI/DI 10198459481673 (each) 40198459481674 (case), Lot Number 26DME349.
Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.
Voluntary or mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States