Data / Medical devices / United States / Avid Medical, Inc. A Medical Action Ind. Company 305
Avid Medical, Inc. A Medical Action Ind. Company 305: FDA-registered device maker in Toano, VA, United States, 14 510(k) clearances
Avid Medical, Inc. A Medical Action Ind. Company 305 is registered with the FDA (registration 1047429) in Toano, VA, United States. It lists 82 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 16, 2020. 29 recall events name it as the recalling firm (7 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1047429
- Address
- 9000 Westmont DR. Stonehouse Commerce Park, Toano, VA, United States, 23168
- Owner or operator
- O & M Halyard, Inc. (10039033)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
- First device listed
- March 6, 2014
- Registered through
- 2026
- Brand names listed
- Absorbent tipped applicator, Adapter, Large, Amniocentesis Kit, Anesthesia Conduction Kit, Anesthesia kit, Arthrogram Kit, Arthrogram tray, Bedding, Disposable, Medical 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 |
| 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 |
| March 10, 2003 | K023808 | IRRIGATION SETS | LJH | Substantially Equivalent | International Medsurg Connection | 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 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 |
| 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 |
| May 21, 1981 | K810921 | MALE LUER LOCK PLUGS | FPA | Substantially Equivalent | Procedure Products, 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 |
|---|---|---|---|---|---|---|
| September 8, 2026 | 99968 | Class II | Ongoing | Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31. | A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. | accessdata.fda.gov |
| August 10, 2026 | 99808 | Class II | Ongoing | DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28 | Product may be potentially contaminated with a lubricant used during the manufacturing process. | accessdata.fda.gov |
| August 10, 2026 | 99758 | Class I | Ongoing | Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02 | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. | accessdata.fda.gov |
| July 22, 2026 | 99764 | Class II | Ongoing | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02 | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator. | accessdata.fda.gov |
| July 22, 2026 | 99761 | Class I | Ongoing | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02. | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. | accessdata.fda.gov |
| July 14, 2026 | 99672 | Class I | Ongoing | Halyard IV START KIT NON-STERILE REF: KRIV26-02 | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides | accessdata.fda.gov |
| July 14, 2026 | 99525 | Class II | Ongoing | Halyard IV Start Kit Non-Sterile REF: KRIV26-02 | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area. | accessdata.fda.gov |
| July 10, 2026 | 99443 | Class II | Ongoing | Halyard LAVH PACK, Model/Catalog Number: USAR053-11 | A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation. | accessdata.fda.gov |
| July 9, 2026 | 99527 | Class II | Ongoing | Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. | accessdata.fda.gov |
| May 19, 2026 | 99469 | Class II | Ongoing | Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. | accessdata.fda.gov |
| May 19, 2026 | 99250 | Class II | Ongoing | Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit. | Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. | accessdata.fda.gov |
| May 7, 2026 | 99249 | Class II | Ongoing | Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. | Incorrect concentration of Betadine solution contained within certain AVID convenience kits. | accessdata.fda.gov |
| April 30, 2026 | 99339 | Class I | Ongoing | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05 | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels. | accessdata.fda.gov |
| April 30, 2026 | 99021 | Class II | Ongoing | Halyard, Pain Pack. Kit Code: AMPK48-01. | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | accessdata.fda.gov |
| March 13, 2026 | 98686 | Class I | Ongoing | Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | accessdata.fda.gov |
| January 2, 2026 | 98298 | Class II | Ongoing | Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. | Tyvek bag seal issue which may compromise sterility of the kit. | accessdata.fda.gov |
| November 14, 2025 | 98045 | Class II | Ongoing | Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. | Potential for incomplete seal on header bag. | accessdata.fda.gov |
| November 11, 2025 | 98060 | Class I | Ongoing | Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. | Devices are not suitable for organ transplant. | accessdata.fda.gov |
| August 4, 2025 | 97452 | Class II | Ongoing | Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. | Potential for open header bag seals, compromising sterility. | accessdata.fda.gov |
| June 11, 2025 | 97149 | Class II | Ongoing | LAPAROSCOPIC TRAY. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | accessdata.fda.gov |
| March 31, 2025 | 96731 | Class II | Ongoing | Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit | An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use. | accessdata.fda.gov |
| September 20, 2024 | 95515 | Class II | Ongoing | Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018 | Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions | accessdata.fda.gov |
| April 9, 2021 | 87720 | Class I | Terminated | ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04 | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical k | accessdata.fda.gov |
| February 18, 2020 | 85049 | Class II | Terminated | Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. | The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to | accessdata.fda.gov |
| July 3, 2017 | 79135 | Class II | Terminated | AVID Medical QA Pack AV10654-10 | The swab stick collection device provided in a convenience kit expires prior to the kit expiration date. | accessdata.fda.gov |
| June 22, 2017 | 79162 | Class II | Terminated | AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09 | Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification. | accessdata.fda.gov |
| March 15, 2017 | 76745 | Class II | Terminated | Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing. | Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. Upon receipt of complaint, AVID Medical promptly initiated an internal investigation and root cause analysis. Investigation found mixed comp | accessdata.fda.gov |
| October 5, 2015 | 73465 | Class II | Terminated | Convenience Kits, MOHS "OPENING" PROCEDURE TRAY | Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex. | accessdata.fda.gov |
| September 9, 2005 | 33335 | Not yet classified | Terminated | Custom Procedure Trays, containing various configurations of medical and surgical devices, packed in plastic pouches, labeled in part ***Avid Medical, The custom procedure tray company Toano, Virginia 23168***Sterile~Dis | Defect in packaging of medical devices may compromise sterility of these products used in medical and surgical procedures. | accessdata.fda.gov |
Compare with other makers
- All makers of Obstetrical Kit
- All makers of Laryngoscope Kit
- All makers of Forceps, Ophthalmic
- All makers of Ear, Nose, And Throat Surgical Tray
- All makers of Wire, Guide, Catheter
- All makers of Hysterectomy Kit
Updated October 22, 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.