Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND... — FDA record Z-1887-2026

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 Feb 27, 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 containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK DYNJ41250B
Reason
Unapproved design changes to the products outside of the 510(k) clearance.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
270,311 total
Agency-reported status
Ongoing
Source record identifier
Z-1887-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityDYNJ34846C UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT 24BBA459 DYNJ83218A UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT 24BBD199 DYNJ85396 UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT 24BBA503 DYNJ905156R UDI-DI 10198459017704 (EA) 40198459017705 (CS) LOTS 24HBG726 24JBJ484 25ABS758 25BBR196 25CBN174 25EBE136 DYNJ905159L UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT 24EMB726 DYNJ905159M UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT 24GMA714 24HMD401 24HMJ945 24JMD201 24KMG592 25AMC024 25BMD945 25CMG373 DYNJ69926A UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT 24ABS445 DYNJ41250B UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT 24ABO122 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

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
Apr 29, 2026
Recall initiation date
Feb 27, 2026
Center classification date
Apr 17, 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.

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