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MEDICAL ACTION INDUSTRIES INC.

US

Last updated May 23, 2026

What MEDICAL ACTION INDUSTRIES INC. makes

Medical Action Industries Inc. manufactures single-use surgical and vascular support products, including non-medicated vascular catheterization and maintenance kits, general surgical procedure kits, and peripheral intravenous catheterization support kits. Their portfolio also includes suture kits, suture removal kits, haemodialysis start/stop sets, and vascular access device flush/disinfection tools. The company produces reusable sharp surgical instrument counting trays and pads.

The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Medical Action Industries Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Medical Action Industries Inc. manufacture?

Medical Action Industries Inc. specializes in single-use surgical and vascular support products. Their portfolio includes non-medicated vascular catheterization and maintenance kits, general surgical procedure kits, peripheral intravenous catheterization support kits, suture kits, suture removal kits, haemodialysis start/stop sets, and vascular access device flush/disinfection tools. They also produce reusable sharp surgical instrument counting trays and pads, which are designed to improve procedural efficiency and safety in clinical settings.

Where is Medical Action Industries Inc. based?

Medical Action Industries Inc. is headquartered in the United States. The company’s location in the US allows it to comply with regional regulatory requirements and serve domestic and potentially international markets where its products are authorized.

Which regulatory registries list Medical Action Industries Inc.’s devices?

Medical Action Industries Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized products, helping healthcare providers and regulators identify and verify the devices in use.

How are Medical Action Industries Inc.’s devices classified under FDA regulations?

Medical Action Industries Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on the specific device type and its intended use, as outlined in FDA guidelines.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
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LinkedIn
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Facebook
—
Email
—
Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
092364462

Catalogue (4362)

Page 4 of 88
DeviceModel / ReferenceRegistriesClassStatus
Medical Action Industries 58681
FDA UDI
Class IUnknown
Medical Action Industries 83826
FDA UDI
Class IIActive
Medical Action Industries 79947B
FDA UDI
Class IActive
Medical Action Industries 79815
FDA UDI
Class IIUnknown
Clear Sequence 78197
FDA UDI
Class IIUnknown
Medical Action Industries 77016
FDA UDI
Class IUnknown
Medical Action Industries 79761
FDA UDI
Class IIActive
Medical Action Industries 71208
FDA UDI
Class IIUnknown
Medical Action Industries 57095B
FDA UDI
Class IIUnknown
Novaplus® 56654
FDA UDI
Class IIUnknown
Medical Action Industries 83881
FDA UDI
Class IIUnknown
Medical Action Industries 75164
FDA UDI
Class IUnknown
Medical Action Industries 71133
FDA UDI
Class IIActive
Medical Action Industries 70517
FDA UDI
Class IIUnknown
Medical Action Industries 76998
FDA UDI
Class IIUnknown
Medical Action Industries 78521B
FDA UDI
Class IIActive
Medical Action Industries 57549C
FDA UDI
Class IIUnknown
Medical Action Industries 56322
FDA UDI
Class IActive
Medical Action Industries 74803
FDA UDI
Class IIUnknown
Medical Action Industries 77664
FDA UDI
Class IIUnknown
Medical Action Industries 81785
FDA UDI
Class IIActive
Medical Action Industries 59584B
FDA UDI
Class IIUnknown
Medical Action Industries 78226
FDA UDI
Class IIActive
Medical Action Industries 71105
FDA UDI
Class IIUnknown
Medical Action Industries 58831B
FDA UDI
Class IIActive
Medical Action Industries LT-9591MAI
FDA UDI
Class IIUnknown
Medical Action Industries 57090
FDA UDI
Class IIActive
Medical Action Industries LT-9620MAI
FDA UDI
Class IIUnknown
Medical Action Industries 76845
FDA UDI
Class IIUnknown
Medical Action Industries 530
FDA UDI
Class IIUnknown
Medical Action Industries 12-818-41
FDA UDI
Class IActive
Medical Action Industries 84010
FDA UDI
Class IIActive
Medical Action Industries 82597C
FDA UDI
Class IIActive
Medical Action Industries 77506B
FDA UDI
Class IIUnknown
Medical Action Industries 79322
FDA UDI
Class IIUnknown
Medical Action Industries 78304
FDA UDI
Class IIActive
Medical Action Industries 82443
FDA UDI
Class IIUnknown
Medical Action Industries 415R
FDA UDI
Class IIUnknown
Medical Action Industries 71837B
FDA UDI
Class IUnknown
Clear Sequence 79377
FDA UDI
Class IIUnknown
Medical Action Industries 76843
FDA UDI
Class IIUnknown
Medical Action Industries 57964
FDA UDI
Class IIUnknown
Medical Action Industries 72735
FDA UDI
Class IIUnknown
Medtonic KPKM002A
FDA UDI
Class IIUnknown
Medical Action Industries NCPM16I
FDA UDI
Class IIActive
Medical Action / Manus AVID337
FDA UDI
Class IUnknown
Medical Action Industries 59551
FDA UDI
Class IIActive
Medical Action Industries 77450B
FDA UDI
Class IIUnknown
Medical Action Industries 81113
FDA UDI
Class IUnknown
Medical Action Industries BMIN42H
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (37)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Medical Action Industries Inc. has 37 recall records initiated between November 6, 2009, and March 17, 2026, with statuses recorded as open, classified, or terminated. The reasons cited include potential sterility compromises—such as breaches of sterile barriers, incomplete seals, or debris—alongside misbranding issues (e.g., incorrect labeling of kits or missing exterior labeling for active ingredients), pH deviations in saline solutions, and mechanical defects (e.g., loose syringe adapters or mismatched expiry dates on components).

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Mar 17, 2026Z-2007-2026—open, classified

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"

Jun 11, 2024Z-3129-2024—open, classified

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.

Jan 15, 2024Z-1394-2024—open, classified

The kits contain saline flush syringes which were recalled by the supplier.

Nov 4, 2022Z-0751-2023—terminated

XXX

Oct 12, 2022Z-0765-2023—terminated

Scissors contained debris.

Oct 12, 2022Z-0464-2023—terminated

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.

Sep 15, 2022Z-0265-2023—terminated

The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.

Sep 8, 2021Z-0147-2022—terminated

The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

May 11, 2021Z-1946-2021—terminated

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021Z-1949-2021—terminated

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021Z-1947-2021—terminated

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021Z-1945-2021—terminated

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

May 11, 2021Z-1948-2021—terminated

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

Apr 9, 2021Z-1557-2021—terminated

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Apr 9, 2021Z-1555-2021—terminated

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Apr 9, 2021Z-1559-2021—terminated

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Apr 9, 2021Z-1554-2021—terminated

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Apr 9, 2021Z-1556-2021—terminated

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Apr 9, 2021Z-1558-2021—terminated

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

Dec 2, 2019Z-0779-2020—terminated

The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0.

Mar 1, 2019Z-1068-2019—terminated

Potential lack of sterility assurance

Nov 27, 2018Z-0681-2019—terminated

Potential compromise of product sterility due to breach of sterile barrier.

Dec 11, 2017Z-2043-2018—terminated

Product sterility potentially compromised.

Apr 19, 2017Z-2102-2017—open, classified

Lint present on sterile Operating Room Towels.

Apr 19, 2017Z-2101-2017—open, classified

Lint present on sterile Operating Room Towels.

Feb 3, 2016Z-1036-2016—terminated

Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling

Jun 12, 2014Z-1953-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Jun 12, 2014Z-1955-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Jun 12, 2014Z-1957-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Jun 12, 2014Z-1954-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Jun 12, 2014Z-1950-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Jun 12, 2014Z-1952-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Jun 12, 2014Z-1956-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Jun 12, 2014Z-1951-2014—terminated

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Nov 6, 2009Z-1074-2010—terminated

Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

Nov 6, 2009Z-1073-2010—terminated

Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

Nov 6, 2009Z-1075-2010—terminated

Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.