Brand Name: Medical Action Industries Product Name: Dialysis Change recall: Convenience kits contain needle free access device that has an improper seal
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2858-2026
- Published
- August 12, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Medical Action Industries, Inc. 306
- Product type
- Medical devices
- Units affected
- 3740 kits (180 cases)
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558
- UPC codes
- 20809160242558
Products covered by this recall
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Check your product
The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 20809160242558
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Medical Action Industries, Inc. 306 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Medical Action Industries, Inc. 306 — 25 Heywood Rd, Arden, NC, 28704-9302
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Medical Action Industries, Inc. 306 medical devices recalled?
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal. Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 20809160242558. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class III · 11 days ago
Medical Action Industries, Inc. 306 recall: An internal data-entry error caused kit lot 333606 to be labeled
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
-
Class II · last month
Medical Action Industries, Inc. 306 Blood Culture Collection Venipuncture Kit 20/Cs recall: Blood culture convenience kits contain a component subject to a drug recall
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the…
-
Class I · last month
Medical Action Industries, Inc. 306 Kit: Single Shot Epidural 20/Cs, REF: 59553 recall: Kits containing Sodium Chloride ampules subject to another recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
-
Class I · last month
Medical Action Industries, Inc. 306 Kit: Epidural/Pain TQC 20/Cs recall: Kits containing Sodium Chloride ampules subject to another recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
-
Class I · 3 months ago
Medical Action Industries, Inc. 306 Pack Angiography Ncmc 3/Cs Banner, REF: Ncag62I recall: Cardiovascular procedure kits contain manifolds
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the…
-
Class I · 6 months ago
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO recall: Convenience kit contains a syringe in which the rotating adapter may unwind
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection…