See RES description — Class II medical device recall Z-2628-2024

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-04. Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. L

Recall number	`Z-2628-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated	2024-04-08
Classified	2024-08-28
Reported by FDA	2024-09-04
Quantity	1,679,067 units
Reason classes	packaging, device malfunction
Lot numbers	`00-398650AJ`, `00-398725AL`, `00-398725AN`, `00-399024AA`, `00-399024AB`, `00-399024Y`, `00-400065L`, `00-400069G`, `00-400123AF`, `00-400305R`, `00-400830R`, `00-401185P`, `00-401226L`, `00-401226M`, `00-401327AB`, `00-401327AC`, `00-401520I`, `00-401610J`, `00-401724J`, `00-401724L`, `00-401800C`, `00-500510G`, `00-HCT055O`, `00-HCT098L`, `00-HCT098M`, `00-HCT098N`, `00-QG7623B`, `00-RDF036N`, `00-RDF036O`, `0M-CP30807I`, `0M-CP31433J`, `0M-CP31796Q`, `0M-CP32229G`, `18LBF682`, `18LBI377`, `18LBI979`, `18LBK462`, `18LBK566`, `18LBK607`, `18LBK629` and 460 more

Product

See RES description

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2628-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.