Recall archive / FDA device enforcement
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A — FDA record Z-2105-2026
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 Jan 7, 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) ADMIT KIT, Model Number: DYKA1343A
- Reason
- Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 1090 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2105-2026
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) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21CBV232; 2) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBB933; 3) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21IBE395; 4) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 21JBF397; 5) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22ABE640; 6) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22EBK467; 7) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22KBA245; 8) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 22LBR618; 9) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23CBE825; 10) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23EBC552; 11) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 23HBP415; 12) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24BBV821; 13) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24DBK171; 14) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 24IBD021; 15) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25DBK346; 16) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25FBN781; 17) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25HBG194; 18) DYKA1343A, UDI-DI: 10193489312966(each), 40193489312967(case), Lot Number: 25LBC732 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - 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
- May 13, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- May 7, 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.