CLASS I ONGOING Device recall · Reported 16 Sep 2026 · FDA Enforcement Report
Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries
Medical Action Industries Inc. 306 is recalling Kit: Epidural/Pain TQC 20/Cs, distributed in Florida, Iowa, Kansas, Missouri, Ohio, Virginia. The recall was initiated on 23 Jul 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-3106-2026
- FDA event ID
- 99613
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 23 Jul 2026
- FDA classified
- 9 Sep 2026
- Reported
- 16 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Jul 2026 | Recall initiated by company | |
| 9 Sep 2026 | Classified by FDA | +48 days |
| 16 Sep 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
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
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
Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Where it was distributed
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
Questions about this recall
Why was it recalled?
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Which lots are affected?
UDI-DI: 10809160367414. Lot(Expiration Date): 322200(4/1/2026), 324586(4/1/2026), 327335(4/1/2026), 329618(9/1/2026), 347199(11/1/2026), 337283(11/1/2026), 350354(11/30/2026), 375449(5/31/2027)
Where was it sold?
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
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 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
1 other product · FDA event 99613This product is part of a recall event; the main page for the event is Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
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