FDA Classifies Medical Action Epidural Kit Correction as Class I
Medical Action Industries is correcting specified epidural kits containing sodium chloride flush ampules subject to a sterility-related recall. FDA classified the issue as a Class I Recall, with matching CDRH records Z-3106-2026 and Z-3107-2026.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
On September 10, 2026, FDA updated its communication on Medical Action Industries' epidural-kit correction and identified the issue as a Class I Recall. The correction covers kits containing 0.9% sodium chloride, USP 10 mL flush ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices, LLC. Medical Action Industries stated that the ampules' sterility may be compromised. FDA says exposure could involve viable microorganisms, endotoxins, or foreign matter, with potential for infection, abscess formation, meningitis, spinal-root compression, paralysis, or death when used near the spine. As of July 23, the company had reported no serious injuries or deaths associated with the issue.
MedTech Current analysis
Why it matters
This event shows how a component-level sterility issue can extend into assembled procedural kits. The Class I classification reflects the potential for serious harm if an affected ampule is used without correction. Organizations using the specified lots need lot-level inventory control and clear separation of the ampule instructions from the status of the remaining kit components.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisHealthcare organizationsReconcile kit inventory by REF, UDI-DI, and lot before the next epidural procedure, and preserve evidence of quarantine or correction.
- MedTech Current analysisQuality and supply-chain teamsCheck whether affected kits were redistributed and ensure the FDA notice reaches every downstream user.
- MedTech Current analysisClinical teamsConfirm the sodium chloride ampule instruction before opening an affected kit and follow the firm's correction notice.
Official recall information
Official actions
According to FDA and Medical Action Industries' official instructions:
- Identify, segregate, and quarantine all impacted kits.
- Add prominent warning labels to affected kits and cases in inventory without covering critical existing product information.
- Remove and discard the Sodium Chloride, 0.9%, USP 10 mL flush ampules before use.
- Do not use the included sodium chloride ampules; remaining kit components may continue to be used only as described in the FDA communication.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
On September 10, 2026, FDA updated its communication on Medical Action Industries’ epidural-kit correction and identified the issue as a Class I Recall. The update followed an August 21 Early Alert. The correction covers kits containing 0.9% sodium chloride, USP 10 mL flush ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices, LLC.
Medical Action Industries stated that the ampules’ sterility may be compromised. FDA says exposure could involve viable microorganisms, endotoxins, or foreign matter, with potential for infection, abscess formation, meningitis, spinal-root compression, paralysis, or death when used near the spine. As of July 23, the company had reported no serious injuries or deaths associated with the issue.
Who and what are affected
The affected products are specified lots of three epidural-kit configurations. CDRH records identify 1,960 kits under Z-3106-2026 and 3,606 kits under Z-3107-2026, for 5,566 kits total.
| Recall number | Product scope | UDI-DI | Quantity |
|---|---|---|---|
| Z-3106-2026 | REF 82465, Epidural/Pain TQC 20/Cs | 10809160367414 | 1,960 |
| Z-3107-2026 | REF 59553 and REF 83945B, Single Shot Epidural 20/Cs | 10809160010518 / 10809160444269 | 3,606 |
The records report U.S. distribution to IA, VA, MO, KS, FL, OH, and LS. Only the specified lots listed in the FDA communication are within scope; organizations should use the notice and CDRH records for the complete lot-level list.
What affected organizations should do
Affected customers
Medical Action Industries’ customer communication recommends that affected customers:
- Identify, segregate, and quarantine impacted kits.
- Add warning labels before continued use, placing them where end users can see them without covering critical product information.
- Remove and discard the Sodium Chloride, 0.9%, USP 10 mL flush ampules before use.
The FDA communication says not to use the included sodium chloride ampules. It also states that remaining kit components may continue to be used as described in the notice. Customers with questions or quality problems should use the contact information in the FDA communication.
MedTech Current analysis
This is a component-level sterility action that extends into assembled procedural kits. Healthcare organizations should reconcile inventory by REF, UDI-DI, and lot, document quarantine or correction, and confirm that any redistributed kits are covered by the same notice. Clinical teams should verify the ampule instruction before opening an affected kit. The Class I designation is tied to the recall action and potential patient harm; it does not mean that every component in each kit must be discarded.