Medline Industries, LP recalls Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU E…
Reason for recall
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
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
- Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKUDT2284570 affected lots20240520902024072690202410039020241212902025020490202504159020250627902025090890
+62 more
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
What the firm is doing
On January 8, 2026, the firm notified affected customers of the product issue through email and first class mail. Customers were instructed to request stickers to over-label affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to returned.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1467-2026
- FDA device classification · OXQOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5075The 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
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm
