Z-3107-2026Class I

Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium...

Name: Z-3107-2026 Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium...
Creator: Medical Action Industries, Inc. 306
Published: 2026-07-23
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2026-07-23 / Open, Classified / root cause: manufacturing process

FDA source

Medical Action Industries, Inc. 306 began a recall of 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 on 2026-07-23. The reason FDA records is "Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3107-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-07-23
Posted: 2026-09-09
Recalling firm: Medical Action Industries, Inc. 306
Product: 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
Product code: OFT Spinal Epidural Anesthesia Kit
Reason for recall: Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 7/23/2026, "Urgent: Medical Device Recall" notices were emailed to customers who were asked to do the following: 1) Identify, Segregate, and Quarantine all impacted kits. 2) Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. 3) REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use. 4) Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5) Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6) Complete and return the Recall Response Form via email to [email protected] Report any quality problems or adverse events associated with the products listed in this notification to [email protected] If you have any questions, contact Regulatory Affairs Manager at email: [email protected].
Quantity in commerce: 3,606
Distribution: US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
Product codes and lots: REF/UDI-DI/Lot(Expiration Date): 59553/10809160010518/330274(9/1/2026), 331036(11/1/2026), 332995(11/1/2026), 333957(11/1/2026), 338894(11/1/2026); 83945B/10809160444269/330827(10/10/2026), 330907(10/10/2026), 333956(11/1/2026), 350340(11/1/2026), 351266(11/30/2026), 373674(5/31/2027)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3107-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3106-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-09
Z-3107-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-09

Product code OFT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)