Z-0177-2027Class II

Medline Industries, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-10-21

Distribution

US Nationwide distribution.

Firm state

Product quantity

1900 kits

Initiated by

Voluntary: Firm initiated

Reason for recall

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.

Product description

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.

Code / lot 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.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →