Data / Medical devices / United States / Medical Action Industries, Inc. 306
Medical Action Industries, Inc. 306: FDA-registered device maker in Arden, NC, United States, 18 510(k) clearances
Medical Action Industries, Inc. 306 is registered with the FDA (registration 1030451) in Arden, NC, United States. It lists 125 device types. The FDA files 18 510(k) clearances under its listings, the newest dated March 16, 2020. 23 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1030451
- Address
- 25 Heywood RD., Arden, NC, United States, 28704
- Owner or operator
- O & M Halyard, Inc. (10039033)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- March 6, 2014
- Registered through
- 2026
- Brand names listed
- Absorbent tipped applicator, Adhesive Felt, Alarm Kit, Amniocentesis Kit, Anesthesia Conduction Kit, Anesthesia kit, Anti Fog Solution, Arthrogram Kit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 16, 2020 | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 9, 2014 | K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| August 2, 2011 | K102158 | SIGMA STERILIZATION POUCH & ROLL | FRG | Substantially Equivalent | Sigma Medical Supplies Corp. | accessdata.fda.gov |
| July 7, 2011 | K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| June 27, 2008 | K080679 | MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | KNT | Substantially Equivalent | Viasys Medsystems | accessdata.fda.gov |
| April 9, 2004 | K040052 | FINE SURGICAL CIRCUMCISION CLAMP | HFX | Substantially Equivalent | Fine Surgical Instrument Corp. | accessdata.fda.gov |
| March 10, 2003 | K023808 | IRRIGATION SETS | LJH | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| March 7, 2003 | K030339 | CAUTERY TIP CLEANER, MODEL-TC-100 | GEI | Substantially Equivalent | Aspen Surgical Products, Inc. | accessdata.fda.gov |
| February 14, 2002 | K020304 | DISPOSABLE LIGHT HANDLE AND ADAPTOR | FTA | Substantially Equivalent | Aspen Surgical Products, Inc. | accessdata.fda.gov |
| February 26, 1999 | K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| October 20, 1997 | K970889 | ULTRASOUND TRANSDUCER DRAPE | KKX | Substantially Equivalent | Protek Medical Products, Inc. | accessdata.fda.gov |
| October 9, 1997 | K971281 | RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE | DQX | Substantially Equivalent | Medcomp | accessdata.fda.gov |
| August 1, 1997 | K971645 | REGANES SPINAL NEEDLE (VARIOUS) | MIA | Substantially Equivalent | Avid N.I.T., Inc. | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| October 7, 1995 | K953573 | ICU STOPCOK WITH EXTENSION TUBING | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 11, 1993 | K932449 | DR. FOG | OCT | Substantially Equivalent | O.R. Concepts, Inc. | accessdata.fda.gov |
| January 30, 1989 | K884792 | VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES | FMI | Substantially Equivalent | Infucare Products, Inc. | accessdata.fda.gov |
| December 19, 1985 | K854816 | EPIDURAL ANESTHESIA NEEDLES | BSP | Substantially Equivalent | Reganes, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 23, 2026 | 99628 | Class II | Ongoing | Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators | 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. | accessdata.fda.gov |
| July 23, 2026 | 99613 | Class I | Ongoing | Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules | Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. | accessdata.fda.gov |
| July 9, 2026 | 99491 | Class III | Ongoing | Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A | 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. | accessdata.fda.gov |
| May 21, 2026 | 99338 | Class II | Ongoing | Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791 | Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal. | accessdata.fda.gov |
| May 13, 2026 | 99337 | Class I | Ongoing | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds | 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. | accessdata.fda.gov |
| March 17, 2026 | 98698 | Class I | Ongoing | Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case | 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" | accessdata.fda.gov |
| June 11, 2024 | 95157 | Class II | Ongoing | Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 | 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. | accessdata.fda.gov |
| January 15, 2024 | 94181 | Class II | Ongoing | IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile. | The kits contain saline flush syringes which were recalled by the supplier. | accessdata.fda.gov |
| November 4, 2022 | 91180 | Class II | Terminated | Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit | XXX | accessdata.fda.gov |
| October 12, 2022 | 91066 | Class II | Terminated | Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile. | Scissors contained debris. | accessdata.fda.gov |
| October 12, 2022 | 91065 | Class II | Terminated | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit. | 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. | accessdata.fda.gov |
| September 15, 2022 | 91017 | Class II | Terminated | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022) | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024. | accessdata.fda.gov |
| September 8, 2021 | 88687 | Class II | Terminated | Kit: Central Line Dres Change 20/Cs | The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. | accessdata.fda.gov |
| May 11, 2021 | 87954 | Class II | Terminated | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits | accessdata.fda.gov |
| April 9, 2021 | 87722 | Class I | Terminated | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. | accessdata.fda.gov |
| December 2, 2019 | 84435 | Class II | Terminated | Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change K | The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0. | accessdata.fda.gov |
| March 1, 2019 | 82289 | Class II | Terminated | Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 4 | Potential lack of sterility assurance | accessdata.fda.gov |
| November 27, 2018 | 81640 | Class II | Terminated | Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are int | Potential compromise of product sterility due to breach of sterile barrier. | accessdata.fda.gov |
| December 11, 2017 | 80147 | Class II | Terminated | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent | Product sterility potentially compromised. | accessdata.fda.gov |
| April 19, 2017 | 77063 | Class II | Ongoing | White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. | Lint present on sterile Operating Room Towels. | accessdata.fda.gov |
| February 3, 2016 | 73237 | Class II | Terminated | PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings | Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling | accessdata.fda.gov |
| June 12, 2014 | 68564 | Class II | Terminated | Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. | Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. | accessdata.fda.gov |
| November 6, 2009 | 53880 | Not yet classified | Terminated | Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | accessdata.fda.gov |
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Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.