CLASS I ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Medline Convenience Kits: Port Access Kit Univ OF Ala recalled
Medline Industries is recalling Medline Convenience Kits: Port Access Kit Univ OF Ala, distributed nationwide in the US. The recall was initiated on 11 Aug 2026 and the FDA has classified it as Class I.
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-3123-2026
- FDA event ID
- 99669
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Aug 2026
- FDA classified
- 14 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 11 Aug 2026 | Recall initiated by company | |
| 14 Sep 2026 | Classified by FDA | +34 days |
| 23 Sep 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
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Which lots are affected?
1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24HBS933; 2) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24HBT600
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 29 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
6 other products · FDA event 99669This product is part of a recall event; the main page for the event is Medline Convenience Kits recalled by Medline Industries.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Medline Convenience Kits recalled by Medline Industries | Medline Industries | Sterility | Nationwide | |
| CLASS I | Medline Convenience Kits: Kit Anesthesia L&d A- Line Set recalled | Medline Industries | Sterility | Nationwide | |
| CLASS I | Medline Convenience Kits recalled by Medline Industries | Medline Industries | Sterility | Nationwide | |
| CLASS I | Medline Convenience Kits: Open Heart Adult recalled | Medline Industries | Sterility | Nationwide | |
| CLASS I | Medline Convenience Kits recalled by Medline Industries | Medline Industries | Sterility | Nationwide | |
| CLASS I | Medline Convenience Kits recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
More recalls from Medline Industries
All 698| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Convenience kits Minor Pack DYNJ58421A Springhill Minor recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS I | Medline Convenience Kits recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Convenience kits Anesthesia Pain PK League DYNJ67925A recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Convenience kits Myringotomy Pack-lf DYNJ59097A recalled | Medline Industries | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,817| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Percutaneous Insertion Kit (PIK), dilator set recalled | Maquet Cardiopulmonary | Sterility | Nationwide |
| Device | CLASS II | Blood Culture Collection Venipuncture Kit 20/Cs recalled | Medical Action Industries Inc. 306 | Sterility | Nationwide |
| Device | CLASS II | CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Aisys, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |