FDA-Device2026-09-16Class IPACKAGING DEFECT
Medical Action Industries epidural/pain kit recalled for compromised sterility
What this means
Medical Action Industries is recalling epidural and pain management kits (REF 82465) that contain sodium chloride ampules. The ampules are subject to a separate recall due to potentially compromised sterility, which could affect the safety of the kits.
- Check if you have one of the affected lot numbers: 322200, 324586, 327335, 329618, 347199, 337283, 350354, or 375449.
- Stop using affected kits immediately.
- Contact Medical Action Industries or your supplier for instructions on return or disposal.
- Consult your facility's infection control and pharmacy teams for guidance.
The agency's original wording
Hazard
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Intended for
Adults
Illnesses reported
None reported
Sold states
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
Affected count
1,960
Manufactured in
25 Heywood Rd, Arden, NC, United States
Products
Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3106-2026More Medical Action Industries recalls
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