Medline Convenience kits used for various procedures: 1) BASIC… — Class II medical device recall Z-1617-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-23, distributed nationwide. There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile co
| Recall number | Z-1617-2025 |
|---|---|
| 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 | 2025-03-03 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, PA |
| Quantity | 3,909 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489244144, 10193489273458, 10193489393958, 10193489448825, 10193489457209, 10193489508024, 10193489612028, 10193489786873, 10193489883503, 10193489916065, 10193489967593, 10193489991062, 10193489994421, 10195327012007, 10195327245221, 10195327266912, 10195327278458, 10195327466176, 10195327486457, 10195327491123, 10195327653149, 10195327668990, 10198459082917, 10198459100277, 10198459122804 and 29 more |
| Lot numbers | 24IBF244, 24IBG352, 24IBG593, 24IBH027, 24IBH266, 24IBH805, 24IBS294, 24IBS393, 24IBS417, 24JBJ668, 24JBN908, 24JBT060, 24JBT766, 24JBU088, 24JBV026, 24JBW137, 24JBX679, 24KBA576, 24KBB063, 24KBC142, 24KBC156, 24KBD242, 24KBD377, 24KBF041, 24KBF076, 24KBF265, 24KBH120, 24KBH238, 24KBH297, 24KBH549, 24KBI136 |
| Model numbers | DYNJ17004L, DYNJ24516F, DYNJ35438F, DYNJ41097A, DYNJ44061, DYNJ44544F, DYNJ44748I, DYNJ45667C, DYNJ47859C, DYNJ48256M, DYNJ49515D, DYNJ50653F, DYNJ55208A, DYNJ55508B, DYNJ57258G, DYNJ60631B, DYNJ63707C, DYNJ63952A, DYNJ67309C, DYNJ67875, DYNJ80082, DYNJ80316A, DYNJ81534B, DYNJ81548B, DYNJ85284 and 2 more |
Product
Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number: DYNJ85284; 6) PHACO PACK, Model Number: DYNJ44748I; 7) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 8) CHOG MINOR OPHTHALMIC PACK, Model Number: SYNJ10271B; 9) LIFESPAN VITRECTOMY PACK, Model Number: DYNJ80082; 10) DR KEYS EYE PACK 2, Model Number: DYNJ48256M; 11) VITRECTOMY PACK, Model Number: DYNJ55508B; 12) EYE PACK, Model Number: DYNJ63952A; 13) VITRECTOMY, Model Number: DYNJ67309C; 14) CATARACT PACK-MARY IMMACUL-LF, Model Number: DYNJ24516F; 15) DR FLOOD EYE PACK, Model Number: DYNJ57258G; 16) BLEPH PACK, Model Number: DYNJ67875; 17) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) OPHTHALMOLOGY PACK, Model Number: SYNJ10259A; 20) PLASTIC EYE, Model Number: DYNJ45667C; 21) BASIC EYE PACK, Model Number: DYNJ81548B; 22) WMC CATARACT PACK-LF, Model Number: DYNJ50653F; 23) BASIC CATARACT, Model Number: DYNJ41097A; 24) PK EYE, Model Number: DYNJ60631B; 25) EYE PLASTIC SURGERY PACK, Model Number: DYNJ44061; 26) CATARACT, Model Number: DYNJ44544F; 27) CATARACT PACK, Model Number: DYNJ49515D; 28) CATARACT PACK, Model Number: DYNJ35438F; 29) OPHTHALMIC PLASTIC PACK, Model Number: DYNJ55208A; 30) CATARACT PACK, Model Number: DYNJ81534B; 31) CATARACT PACK, Model Number: DYNJ49515D
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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-1617-2025. 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.