Medical Action Industries, Inc. 306 recalls Kit: Single Shot Epidural 20/Cs
Reason for recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Kit: Single Shot Epidural 20/Cs1 code
- 59553
Kit: Single Shot Epidural 20/Cs3 codes
- 83945B. Containing Sodium Chloride Injection
- 0.9%
- USP 10ml ampules
Lot / code information
- 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) — +4 moreShow all
(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)
What the firm is doing
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 GM-OMRA_RECALLS@owens-minor.com Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com If you have any questions, contact Regulatory Affairs Manager at email: GM-OMRA_RECALLS@owens-minor.com.
DistributionShow detailsHide
US distribution to states of: IA, VA, MO, KS, FL, OH and LS.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3107-2026
- FDA device classification · OFTOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5120The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medical Action Industries, Inc. 306Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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