Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 10195327556761 (EA) 40195327556762 (CS)
- Lot #
- 24CMG485 DYNJ905153N
- UDI
- 10198459017797 (EA) 40198459017798 (CS)
- Lot #
- 25DMC254 DYNJ81602
- UDI
- 10195327123857 (EA) 40195327123858 (CS)
- Lot #
- 24ABP080 DYNJ905157K
- UDI
- 10195327556921 (EA) 40195327556922 (CS) LOTS 24DMF349 24EMC297 DYNJ905157L
- UDI
- 10198459017711 (EA) 40198459017712 (CS) LOTS 24FMD083 24HMD400 24IME332 24JMA234 24KMG588 25AMA393 25AMJ541 25BMI202 25CMD909 25CMH371 DYNJ46675G
- UDI
- 10195327419066 (EA) 40195327419067 (CS)
- Lot #
- 24ABS814 DYNJ81607
- UDI
- 10195327123918 (EA) 40195327123919 (CS)
- Lot #
- 24ABP097 DYNJ905160O
- UDI
- 10198459017742 (EA) 40198459017743 (CS) LOTS 24HMG093 24IME714 24JMI924 24LMB556 25AME613 25BMJ076 DYNJ81599
- UDI
- 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 24IMG2…Show all
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
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What the firm is doing
On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1881-2026
- FDA device classification · FDEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1500The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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