Food, drugs, devices › Medical Action Industries, Inc. 306
Device recall: Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
FDA enforcement event 99613 is a device recall by Medical Action Industries, Inc. 306 of Arden, NC, initiated 23 Jul 2026 and classified Class I, with 2 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 12% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medical Action Industries, Inc. 306 has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medical Action Industries, Inc. 306, Arden, NC.
Reason for recall
"Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility."
Distribution
"US distribution to states of: IA, VA, MO, KS, FL, OH and LS."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3106-2026 | Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules | 1,960 | Class I | Ongoing | 16 Sep 2026 |
| Z-3107-2026 | Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules | 3,606 | Class I | Ongoing | 16 Sep 2026 |
Context
Other enforcement events for Medical Action Industries, Inc. 306
All 15 events for Medical Action Industries, Inc. 306
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to states of: IA, VA, MO, KS, FL, OH and LS."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.