Recall archive / FDA device enforcement

Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P — FDA record Z-2104-2026

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) PPE KIT, Model Number: DYK1011945P
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: 13025 units
Agency-reported status: Ongoing
Source record identifier: Z-2104-2026

Open the official record

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) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21BFA109; 2) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21EFA047; 3) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21FFA074; 4) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21GFA025; 5) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21HFA112; 6) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21IFA100; 7) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA039; 8) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA139; 9) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21KFA114; 10) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22BFA066; 11) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22CFA086; 12) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22DFA081; 13) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22IFA036; 14) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22JFA111; 15) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22LFA068; 16) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA049; 17) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA090; 18) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA006; 19) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA124; 20) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23CFA070; 21) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23DFA024; 22) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA007; 23) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA070; 24) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23GFA079; 25) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA039; 26) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA117; 27) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA178; 28) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23IFA139; 29) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23JFA065; 30) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA006; 31) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA054; 32) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23LFA050; 33) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24BFA115; 34) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24FFA115; 35) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24GFA027; 36) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24IFA085; 37) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA035; 38) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA136; 39) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24KFA099; 40) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25CFA033; 41) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25DFA033; 42) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25FFA025; 43) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25GFA099; 44) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25IFA006

Label field

Details supplied by the agency

Lot, code or applicability

1) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21BFA109; 2) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21EFA047; 3) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21FFA074; 4) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21GFA025; 5) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21HFA112; 6) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21IFA100; 7) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA039; 8) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA139; 9) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21KFA114; 10) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22BFA066; 11) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22CFA086; 12) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22DFA081; 13) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22IFA036; 14) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22JFA111; 15) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22LFA068; 16) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA049; 17) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA090; 18) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA006; 19) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA124; 20) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23CFA070; 21) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23DFA024; 22) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA007; 23) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA070; 24) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23GFA079; 25) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA039; 26) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA117; 27) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA178; 28) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23IFA139; 29) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23JFA065; 30) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA006; 31) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA054; 32) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23LFA050; 33) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24BFA115; 34) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24FFA115; 35) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24GFA027; 36) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24IFA085; 37) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA035; 38) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA136; 39) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24KFA099; 40) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25CFA033; 41) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25DFA033; 42) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25FFA025; 43) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25GFA099; 44) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25IFA006

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.

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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records