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.
Affected products & lots
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACKDYNJ908706DUDI-DI 1019532733819020 affected lots24GMH51024HMG886DYNJ908706D101984590177734019845901777424HMA78324HMG30824KMC651
+12 more
24KMJ27424LME93125AME21725BMI6535/20/26DYNJ909398A23EMF07823HME51223HMI26923JMB52823KME17524EMC327
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-1885-2026
- FDA device classification · OHDOfficial FDA classification for this device type
- CFR regulation · 21 CFR 884.1720The 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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