Is this your brand? Sign in to claim ownership.
Sign in to claim this brandOWENS & MINOR DISTRIBUTION, INC.
US
Last updated May 23, 2026
What OWENS & MINOR DISTRIBUTION, INC. makes
The company produces single-use surgical and procedural supplies, including general surgical procedure kits, first aid kits, and medical drapes, as well as reusable instrument trays. It also manufactures peripheral intravenous catheterization support kits and professional examination gowns, alongside specialized testers for electrosurgical and ultrasonic surgical systems. Sterilization packaging for medical instruments is another core product.
These devices are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device regulations.
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 Owens & Minor Distribution, Inc. manufacture?
Owens & Minor Distribution, Inc. specializes in a range of medical devices, primarily focused on single-use surgical and procedural supplies. Their portfolio includes general surgical procedure kits, first aid kits, medical drapes, and professional examination gowns. They also produce reusable instrument trays, peripheral intravenous catheterization support kits, and specialized testers for electrosurgical and ultrasonic surgical systems. Additionally, they offer sterilization packaging for medical instruments, ensuring compatibility with various clinical and procedural needs.
Where is Owens & Minor Distribution, Inc. based, and how does this affect its devices?
Owens & Minor Distribution, Inc. is based in the United States, which means its devices are subject to U.S. medical device regulations. This includes compliance with FDA requirements for classification, labeling, and post-market surveillance. Being U.S.-based also influences the regulatory pathways and standards the company follows, such as adherence to FDA’s Unique Device Identifier (UDI) system for traceability and recall management.
Which regulatory registries or databases list devices manufactured by Owens & Minor Distribution, Inc.?
Devices produced by Owens & Minor Distribution, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and use, ensuring better tracking, safety monitoring, and regulatory compliance. This listing helps healthcare providers, regulators, and other stakeholders verify device details and maintain transparency in the supply chain.
How are devices from Owens & Minor Distribution, Inc. classified under FDA regulations?
The devices manufactured by Owens & Minor Distribution, Inc. fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and often require only general controls like good manufacturing practices. Class II devices involve a higher level of risk and may require special controls in addition to general controls, such as performance standards or post-market surveillance. The classification determines the regulatory scrutiny and compliance requirements each device must meet.
What does it mean for a device from Owens & Minor Distribution, Inc. to be listed in the FDA’s UDI database?
Listing in the FDA’s UDI database means the device has been assigned a unique identifier, combining a device identifier (like a model number) and a production identifier (like a batch or lot number). This system improves traceability, enabling faster recalls, better inventory management, and enhanced patient safety by linking devices to their manufacturing details. It also supports regulatory oversight by providing clear, standardized information about each device’s history and compliance status.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 007941230
Catalogue (10619)
Page 1 of 213| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SurgiTrack | 4500PHMT01 | FDA UDI | Class II | Active |
| SurgiTrack | 450071GA07 | FDA UDI | Class II | Active |
| SurgiTrack | 450020HH01 | FDA UDI | Class II | Active |
| SurgiTrack | 450071AH24 | FDA UDI | Class II | Active |
| SurgiTrack | 450044MX58 | FDA UDI | Class II | Active |
| Medichoice | CL7202 | FDA UDI | Class II | Active |
| SurgiTrackSM | 4500714CB0 | FDA UDI | Class II | Active |
| SurgiTrack | 450168OFBP | FDA UDI | Class II | Active |
| SurgiTrack | 4500PHLD05 | FDA UDI | Class II | Active |
| SurgiTrack | 4500LRKA02 | FDA UDI | Class II | Active |
| SurgiTrack | 450044BB01 | FDA UDI | Class II | Active |
| SurgiTrack | 450071AS07 | FDA UDI | Class II | Active |
| SurgiTrack | 450020TF12 | FDA UDI | Class II | Active |
| SurgiTrack | 450030AS88 | FDA UDI | Class II | Active |
| SurgiTrack | 450084HR19 | FDA UDI | Class II | Active |
| SurgiTrackSM | 450092SI05 | FDA UDI | Class II | Active |
| SurgiTrack | 450078TY05 | FDA UDI | Class II | Active |
| SurgiTrackSM | 450144AD01 | FDA UDI | Class II | Active |
| SurgiTrackSM | 450070B1EC | FDA UDI | Class II | Active |
| SurgiTrack | 4500UYAF51 | FDA UDI | Class II | Active |
| SurgiTrackSM | 4500201B8C | FDA UDI | Class II | Active |
| MediChoice | CLC2014 | FDA UDI | Class II | Active |
| SurgiTrackSM | 450051ECDE | FDA UDI | Class II | Active |
| SurgiTrack | 4500OMCY01 | FDA UDI | Class II | Active |
| SurgiTrack | 4500SFLV14 | FDA UDI | Class II | Active |
| SurgiTrack | 4500WRTK01 | FDA UDI | Class II | Active |
| SurgiTrack | 450082AH02 | FDA UDI | Class II | Active |
| MediChoice | TRN1183 | FDA UDI | Class I | Active |
| SurgiTrack | 450071HN12 | FDA UDI | Class II | Active |
| SurgiTrack | 4500VVTH02 | FDA UDI | Class II | Active |
| SurgiTrack | 450044RR02 | FDA UDI | Class II | Active |
| SurgiTrackSM | 450059F175 | FDA UDI | Class II | Active |
| SurgiTrack | 4500PHAS02 | FDA UDI | Class II | Active |
| Medichoice | 994630 | FDA UDI | Class I | Active |
| SurgiTrackSM | 4500700CFB | FDA UDI | Class II | Active |
| SurgiTrack | 450044AA02 | FDA UDI | Class II | Active |
| SurgiTrackSM | 450037943C | FDA UDI | Class II | Active |
| MediChoice | GEY1WL | FDA UDI | Class I | Active |
| Medichoice | CL2216 | FDA UDI | Class II | Active |
| SurgiTrack | 4500UYAK50 | FDA UDI | Class II | Active |
| Halyard | 55962 | FDA UDI | Class II | Active |
| SurgiTrack | 450075SB02 | FDA UDI | Class II | Active |
| Medichoice | ORT06B | FDA UDI | Class II | Active |
| SurgiTrack | 450082TK01 | FDA UDI | Class II | Active |
| SurgiTrack | 450037NS05 | FDA UDI | Class II | Active |
| SurgiTrack | 450087HT50 | FDA UDI | Class II | Active |
| Medichoice | RSC10D | FDA UDI | Class II | Active |
| SurgiTrack | 450020NC01 | FDA UDI | Class II | Active |
| MediChoice | 58277 | FDA UDI | Class I | Active |
| SurgiTrackSM | 450048E32F | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Owens & Minor Distribution, Inc. has nine recall records initiated between November 3, 2003, and January 3, 2023, with statuses including open, classified, and terminated. The reasons cited involve quality deviations such as rayon loosening in applicators, loose or misaligned product wheels, potential sterility compromises in sealed pouches, mislabeling of face masks with incorrect ear-loop dispensers, counterfeit medical devices, and microbial contamination in sterile cohesive bandages. Some records reference customer complaints as the source of the identified issues, while others involve private-label distribution of products manufactured abroad.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 3, 2023 | Z-1059-2023 | — | open, classified | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops. |
| Oct 31, 2022 | Z-0343-2023 | — | open, classified | Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection |
| Oct 31, 2016 | Z-0888-2017 | — | terminated | Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc. Owens & Minor first learned of the product issue that prompted the product removal action via customer complaints received in September 2016. Two customer complaints received on September 1"1, 2016 reported surface contamination on the arm slings. Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue. Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions. A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016. The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots. Owens & Minor has quarantined the affected product lots. The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time. Based on the frequency of the product defect as well as evaluation of potential adverse health event risk, Owens & Minor initiated a voluntary recall for the above stated affected product lots. |
| Nov 17, 2015 | Z-0734-2016 | — | terminated | MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. |
| Nov 17, 2015 | Z-0735-2016 | — | terminated | MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. |
| Nov 17, 2015 | Z-0733-2016 | — | terminated | MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. |
| Jun 25, 2014 | Z-0416-2015 | — | terminated | Product wheels may be too loose, too tight, or fall off. |
| Mar 26, 2013 | Z-1192-2013 | — | terminated | Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use. |
| Nov 3, 2003 | Z-0251-04 | — | terminated | Counterfeit product is an unapproved medical device with associated potential health hazard. |