Recall archive / FDA device enforcement
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905... — FDA record Z-1881-2026
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 BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599
- 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-1881-2026
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 | DYNJ905153M UDI-DI 10195327556761 (EA) 40195327556762 (CS) LOT 24CMG485 DYNJ905153N UDI-DI 10198459017797 (EA) 40198459017798 (CS) LOT 25DMC254 DYNJ81602 UDI-DI 10195327123857 (EA) 40195327123858 (CS) LOT 24ABP080 DYNJ905157K UDI-DI 10195327556921 (EA) 40195327556922 (CS) LOTS 24DMF349 24EMC297 DYNJ905157L UDI-DI 10198459017711 (EA) 40198459017712 (CS) LOTS 24FMD083 24HMD400 24IME332 24JMA234 24KMG588 25AMA393 25AMJ541 25BMI202 25CMD909 25CMH371 DYNJ46675G UDI-DI 10195327419066 (EA) 40195327419067 (CS) LOT 24ABS814 DYNJ81607 UDI-DI 10195327123918 (EA) 40195327123919 (CS) LOT 24ABP097 DYNJ905160O UDI-DI 10198459017742 (EA) 40198459017743 (CS) LOTS 24HMG093 24IME714 24JMI924 24LMB556 25AME613 25BMJ076 DYNJ81599 UDI-DI 10195327124021 (EA) 40195327124022 (CS) LOT 24BBB847 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ905153M lots 24BMH968 24EMG682; DYNJ905153N lots 24HMG087 24IMA442 24IMG245; DYNJ905157K lots 23LME674 24AMH261 24AMJ205 24BME886 24CMD057 |
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.
- 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
- 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.