CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report
Medline Kits containing Tego Connectors: Medline IR Pack recalled
Medline Industries is recalling Medline Kits containing Tego Connectors: Medline IR Pack, distributed nationwide in the US. The recall was initiated on 8 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1463-2026
- FDA event ID
- 98333
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jan 2026
- FDA classified
- 24 Feb 2026
- Reported
- 4 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jan 2026 | Recall initiated by company | |
| 24 Feb 2026 | Classified by FDA | +47 days |
| 4 Mar 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Where it was distributed
US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
IR PACK UDI-DI (ea) 10195327621780 UDI-DI (case) 40195327621781 Kit lots 24BBP627 24DBO029 24FBI148 24JBA858 24KBD925 24LBG978 25ABQ002 25EBV162; NO CATHETER DIALYSIS INSERTION UDI-DI (ea) 10195327675219 UDI-DI (case) 40195327675210 Kit Lots 24EBM915 24GBC287
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 98333This product is part of a recall event; the main page for the event is Medline Kits containing Tego Connectors Medline Dialysis ON/OFF KIT recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline Kits containing Tego Connectors Medline Dialysis ON/OFF KIT recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Convenience kits containing Tego Connectors Medline recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Convenience kits used for dialysis maintenance Medline Add recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Convenience kits containing Tego Connectors recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline kits containing Tego Connectors Medline Apheresis recalled | Medline Industries | Packaging Defects | Nationwide |
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