Recall archive / FDA device enforcement
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP ... — FDA record Z-3061-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B
- Reason
- The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 2080 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3061-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24LBQ727; 2) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24JBB775; 3) DYKM2751A, UDI-DI: 10198459313301(each), 40198459313302(case), Lot Number: 25KMD727; 4) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24KBP388; 5) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24JBA739; 6) DYKS1583B, UDI-DI: 10198459292699(each), 40198459292690(case), Lot Number: 25DBM037 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 9, 2026
- Recall initiation date
- Jun 12, 2026
- Center classification date
- Aug 31, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.