Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling 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 DYNJ905. Reason: Unapproved design changes to the products outside of the 510(k) clearance.
What is being recalled
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
Why
Unapproved design changes to the products outside of the 510(k) clearance.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1881-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 27, 2026 |
| Reported | April 29, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 270,311 total |
More recalls from Medline Industries, LP · all medical device recalls · recalls from February 2026