CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Medical Action Industries Dialysis Change Tray Clear Sequence recalled
Medical Action Industries Inc. 306 is recalling Medical Action Industries Dialysis Change Tray Clear Sequence, distributed nationwide in the US. The recall was initiated on 21 May 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-2858-2026
- FDA event ID
- 99338
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 3 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 21 May 2026 | Recall initiated by company | |
| 3 Aug 2026 | Classified by FDA | +74 days |
| 12 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
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
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Where it was distributed
US Nationwide distribution in the state of CA.
Questions about this recall
Why was it recalled?
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
Which lots are affected?
Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558
Where was it sold?
US Nationwide distribution in the state of CA.
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.
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