FDA Medical devices recall ·
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG… recall
- Recall number
- Z-1468-2026
- Date
- (initiated January 8, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 150
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1468-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.