Recall Record

Arden, NC, United States

Medical Action Industries, Inc. 306 recalls

16 recalls recorded since 2018, most recently on 23 July 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.

Recalls16
Ongoing (FDA)8
Terminated or completed8
Class I (FDA)4

Ongoing Class I Medical devices

Recall started
23 July 2026
Reason
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.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-3107-2026, Z-3106-2026

Ongoing Class II Medical devices

Recall started
23 July 2026
Reason
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.
Distribution
US Nationwide distribution in the states of OH, IN, NC.
Initiated
Voluntary: Firm initiated
Recall number
Z-3181-2026

Ongoing Class III Medical devices

Recall started
9 July 2026
Reason
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
Distribution
U.S.: CA O.U.S.: N/A
Initiated
Voluntary: Firm initiated
Recall number
Z-0069-2027

Ongoing Class II Medical devices

Recall started
21 May 2026
Reason
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
Distribution
US Nationwide distribution in the state of CA.
Initiated
Voluntary: Firm initiated
Recall number
Z-2858-2026

Ongoing Class I Medical devices

Recall started
13 May 2026
Reason
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
Distribution
US: AZ, CO
Initiated
Voluntary: Firm initiated
Recall number
Z-2792-2026

Ongoing Class I Medical devices

Recall started
17 March 2026
Reason
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Distribution
US distribution to state of: AZ OUS: None
Initiated
Voluntary: Firm initiated
Recall number
Z-2007-2026

Ongoing Class II Medical devices

Recall started
11 June 2024
Reason
The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN.
Distribution
Nationwide distribution. International distribution to Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-3129-2024

Ongoing Class II Medical devices

Recall started
15 January 2024
Reason
The kits contain saline flush syringes which were recalled by the supplier.
Distribution
US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-1394-2024

Terminated Class II Medical devices

Recall started
4 November 2022
Terminated
18 March 2026
Reason
XXX
Distribution
US Nationwide distribution in the state of VA.
Initiated
Voluntary: Firm initiated
Recall number
Z-0751-2023

Terminated Class II Medical devices

Recall started
12 October 2022
Terminated
25 March 2025
Reason
The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
Distribution
Distribution was made to MN. There was no foreign/government/military distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-0464-2023

Terminated Class II Medical devices

Recall started
12 October 2022
Terminated
19 February 2025
Reason
Scissors contained debris.
Distribution
Distribution was made to FL, IL, IN, MA, MD, MO, OH, and VA. There was no foreign/government/military distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-0765-2023

Terminated Class II Medical devices

Recall started
15 September 2022
Terminated
19 February 2025
Reason
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Distribution
US Nationwide distribution in the state of Pennsylvania.
Initiated
Voluntary: Firm initiated
Recall number
Z-0265-2023

Terminated Class II Medical devices

Recall started
8 September 2021
Terminated
13 October 2023
Reason
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Distribution
Distribution to a single US distributor in Michigan
Initiated
Voluntary: Firm initiated
Recall number
Z-0147-2022

Terminated Class II Medical devices

Recall started
11 May 2021
Terminated
10 May 2023
Reason
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Distribution
US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1947-2021, Z-1949-2021, Z-1946-2021, Z-1948-2021, Z-1945-2021

Terminated Class I Medical devices

Recall started
9 April 2021
Terminated
3 October 2023
Reason
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Distribution
Distributed US nationwide to OH, OR, FL and CA.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1557-2021, Z-1554-2021, Z-1558-2021, Z-1556-2021, Z-1555-2021, Z-1559-2021

Terminated Class II Medical devices

Recall started
2 December 2019
Terminated
24 January 2023
Reason
The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.
Distribution
MA, RI, PA, MD, VA, NC, SC, GA, FL, KY, OH, IN, MI, IL, MO, NE, LA, TX, AZ, CA, WA
Initiated
Voluntary: Firm initiated
Recall number
Z-0779-2020

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.