Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097...
FDA Device Recall #Z-1617-2025 — Class II — March 3, 2025
Recall Summary
| Recall Number | Z-1617-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 3, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 3909 units |
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Lot / Code Information
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-DI: 10193489393958(each), 40193489393959(case), Lot Number: 24JBT060; 13) DYNJ67309C, UDI-DI: 10195327668990(each), 40195327668991(case), Lot Number: 24JBT766; 14) DYNJ24516F, UDI-DI: 10195327278458(each), 40195327278459(case), Lot Number: 24JBU088; 15) DYNJ57258G, UDI-DI: 10195327491123(each), 40195327491124(case), Lot Number: 24JBV026; 16) DYNJ67875, UDI-DI: 10193489448825(each), 40193489448826(case), Lot Number: 24JBW137; 17) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 24JBX679; 18) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24KBA576; 19) SYNJ10259A, UDI-DI: 10193489786873(each), 40193489786874(case), Lot Number: 24KBB063; 20) DYNJ45667C, UDI-DI: 10193489991062(each), 40193489991063(case), Lot Number: 24KBC142; 21) DYNJ81548B, UDI-DI: 10198459100277(each), 40198459100278(case), Lot Number: 24KBC156; 22) DYNJ50653F, UDI-DI: 10195327653149(each), 40195327653140(case), Lot Number: 24KBD242; 23) DYNJ41097A, UDI-DI: 10888277213487(each), 40888277213488(case), Lot Number: 24KBD377; 24) DYNJ60631B, UDI-DI: 10193489994421(each), 40193489994422(case), Lot Number: 24KBF041; 25) DYNJ44061, UDI-DI: 10888277081994(each), 40888277081995(case), Lot Number: 24KBF076; 26) DYNJ44544F, UDI-DI: 10198459122804(each), 40198459122805(case), Lot Number: 24KBF265; 27) DYNJ49515D, UDI-DI: 10193489508024(each), 40193489508025(case), Lot Number: 24KBH120; 28) DYNJ35438F, UDI-DI: 10193489612028(each), 40193489612029(case), Lot Number: 24KBH238; 29) DYNJ55208A, UDI-DI: 10193489967593(each), 40193489967594(case), Lot Number: 24KBH297; 30) DYNJ81534B, UDI-DI: 10198459082917(each), 40198459082918(case), Lot Number: 24KBH549; 31) DYNJ49515D, UDI-DI: 10193489508024(each), 40193489508025(case), Lot Number: 24KBI136
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.