FDA Device recall Z-1617-2025
Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A by Medline Industries Northfield, citing there is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1617-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-03 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Identifiers
| code_info | 1) DYNJ41097A, UDI-DI: 10888277213487(each), 40888277213488(case), Lot Number: 24IBF244; 2) DYNJ60631B, UDI-DI: 1019348…1) DYNJ41097A, UDI-DI: 10888277213487(each), 40888277213488(case), Lot Number: 24IBF244; 2) DYNJ60631B, UDI-DI: 10193489994421(each), 40193489994422(case), Lot Number: 24IBG352; 3) DYNJ80316A, UDI-DI: 10195327245221(each), 40195327245222(case), Lot Number: 24IBG593; 4) DYNJ63707C, UDI-DI: 10193489883503(each), 40193489883504(case), Lot Number: 24IBH027; 5) DYNJ85284, UDI-DI: 10195327486457(each), 40195327486458(case), Lot Number: 24IBH266; 6) DYNJ44748I, UDI-DI: 10193489273458(each), 40193489273459(case), Lot Number: 24IBH805; 7) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 24IBS294; 8) SYNJ10271B, UDI-DI: 10193489457209(each), 40193489457200(case), Lot Number: 24IBS393; 9) DYNJ80082, UDI-DI: 10195327012007(each), 40195327012008(case), Lot Number: 24IBS417; 10) DYNJ48256M, UDI-DI: 10195327466176(each), 40195327466177(case), Lot Number: 24JBJ668; 11) DYNJ55508B, UDI-DI: 10195327266912(each), 40195327266913(case), Lot Number: 24JBN908; 12) DYNJ63952A, UDI-D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1617-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.