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 EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACKDYNJ41250BUDI-DI 1019348978144147 affected lots24BBA459DYNJ83218A101953273823084019532738230924BBD199DYNJ853961019532749761340195327497614
+39 more
24BBA503DYNJ905156R101984590177044019845901770524HBG72624JBJ48425ABS75825BBR19625CBN17425EBE136DYNJ905159L101953276642514019532766425224EMB726DYNJ905159M101984590177354019845901773624GMA71424HMD40124HMJ94524JMD20124KMG59225AMC02425BMD94525CMG373DYNJ69926A101953271536014019532715360224ABS445DYNJ41250B108882778012574088827780125824ABO1225/20/26DYNJ905156R24GBD13524IBK56324IBS86225BBH767
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-1887-2026
- FDA device classification · OJHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The 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.
More Class II recalls
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) BASIC PACK
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Eye Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Orthopedic Tray
- Nonconforming Material/Component
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Neurological Tray
- Nonconforming Material/Component