CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Medical Action Industries Inc. Pack Cath BHH recalled
Medical Action Industries, Inc. 306 is recalling Medical Action Industries Inc. Pack Cath BHH, distributed in Arizona. The recall was initiated on 17 Mar 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-2007-2026
- FDA event ID
- 98698
- Recalling firm
- Medical Action Industries, Inc. 306, Arden, NC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 17 Mar 2026
- FDA classified
- 6 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 17 Mar 2026 | Recall initiated by company | |
| 6 May 2026 | Classified by FDA | +50 days |
| 13 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
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
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Where it was distributed
US distribution to state of: AZ OUS: None
Questions about this recall
Is Medical Action Industries Inc. Pack Cath BHH recalled?
Yes. Medical Action Industries, Inc. 306 recalled Medical Action Industries Inc. Pack Cath BHH on 17 Mar 2026. The recall is Class I and its status is Ongoing. Recall number Z-2007-2026.
Why was it recalled?
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Which lots are affected?
UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789
Where was it sold?
US distribution to state of: AZ OUS: None
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medical Action Industries, Inc. 306
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|---|---|---|---|---|---|
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Medical Action Industries Dialysis Change Tray Clear Sequence recalled | Medical Action Industries, Inc. 306 | Packaging Defects | Nationwide |
| Device | CLASS I | Pack Angiography Ncmc 3/Cs Banner recalled by Medical Action Industries | Medical Action Industries, Inc. 306 | Particulate Matter | AZ, CO |
| Device | CLASS II | Foam Protective recalled by Medical Action Industries | Medical Action Industries, Inc. 306 | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |