Device recall

Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.

FDA recall source

Recall number

Z-0177-2027

Event id

99886

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Oct 21, 2026

Posted

Oct 15, 2026

Initiated

Sep 2, 2026

Center classification date

Oct 15, 2026

Product code

OJG

Device type

Neurological Tray

Reason

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Root cause

Under Investigation by firm

Quantity

1900 kits

Code info

Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26BBC545; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 26ABM193; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25LBD334; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25JBL305; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25IBF209; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25HBI041; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25FBF808; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25EBO692; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25DBG912; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25BBS302; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 25ABN459; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24LBQ417; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBL387; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24KBB074; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24IBI827; Medline product number/SKU DYNJ80055A, UDI/DI 10198459093425 (each) 40198459093426 (case), Lot number 24HBL301; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22CLA280; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 22ALA687; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21KLA284; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21JLA298; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21HLA613; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21GLA706; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21DLA076; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 21ALA482; Medline product number/SKU DYNJ24528M, UDI/DI 10193489678222 (each) 40193489678223 (case), Lot number 20LLA600.

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States