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Sign in to claim this brandREMINGTON MEDICAL, INC.
United States·US-MF-000002612
Last updated September 17, 2026
What REMINGTON MEDICAL, INC. makes
Remington Medical, Inc. manufactures single-use needles for medical procedures, including body aspiration, epidural insertion, prostate and bone marrow biopsy, and intra-arterial access. Their portfolio also includes vascular catheter introduction sets and general-purpose syringes. Additionally, they produce diagnostic tools like laser Doppler blood flowmeters, which measure blood flow in tissues.
The company’s devices are regulated under FDA Class I and Class II (including Class IIa) classifications and are listed in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identifier (UDI) registry. The manufacturer 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 Remington Medical, Inc. manufacture?
Remington Medical, Inc. specializes in single-use medical devices primarily focused on needles and related tools. Their portfolio includes body aspiration needles, epidural needles (non-threaded), prostate and bone marrow biopsy needles, intra-arterial needles, and general-purpose syringes. They also produce vascular catheter introduction sets and diagnostic tools like laser Doppler blood flowmeters, which assess tissue blood flow. These devices are designed for procedures requiring precision access or measurement.
Where is Remington Medical, Inc. based, and how does that affect its regulatory standing?
Remington Medical, Inc. is based in the United States. Since the company operates under U.S. regulatory oversight, its devices are evaluated and listed in the FDA’s systems, including the 510(k) premarket notification database and the Unique Device Identifier (UDI) registry. This means their products must comply with FDA requirements for classification (Class I or Class II/IIa) and are tracked accordingly. The EUDAMED database also lists their devices, indicating they are marketed in the European Economic Area.
Which regulatory registries list Remington Medical, Inc.’s devices?
Remington Medical, Inc.’s devices are listed in multiple global regulatory registries to ensure transparency and compliance. They appear in EUDAMED, the European database for medical devices, as well as the FDA’s 510(k) premarket notifications and FDA’s UDI registry, which catalogs U.S.-authorized devices by their unique identifiers. These listings reflect their distribution in both the U.S. and the European Economic Area.
How are Remington Medical, Inc.’s devices classified under U.S. and EU regulations?
Remington Medical, Inc.’s devices fall under FDA Class I (low-risk, generally exempt from premarket review) or Class II/IIa (moderate-risk, requiring special controls or premarket submissions). Class II/IIa devices often include needles and biopsy tools due to their procedural risks, while Class I may cover simpler single-use items like general-purpose syringes. In the EU, these classifications align with MDD/IVDR risk categories, though exact EU classification isn’t specified here. The company’s devices are authorized separately in each market based on their specific risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 6830, Meadowridge Court, Alpharetta, United States
- Website
- remmed.com
- —
- —
- [email protected]
- Phone
- +1(800)989-0057
- PRRC Contact
- Dorothy Frieser
- EUDAMED SRN
- US-MF-000002612
- FDA FEI Number
- 1000132370
- DUNS Number
- 788472314
Catalogue (224)
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FDA Recalls (20)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Remington Medical, Inc. has 20 recall records spanning from February 15, 2005, to November 3, 2023, with statuses recorded as open, classified, or terminated. The reasons cited include issues such as leakage in drainage bags, potential needle hub breakage, mislabeling of use-by dates and manufacturer dates, incorrect needle packaging, compromised sterility, improper sealing of pouches, incorrect polarity instructions, cable disconnection risks, incorrect stylet length labeling, cracked or improperly peeled sheaths in introducer kits, and an electrical design flaw in vector selectors.
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 |
|---|---|---|---|---|
| Nov 3, 2023 | Z-0487-2024 | — | open, classified | There is an error with the "Use by Date" and "Date of Manufacturer" on the box label. |
| Dec 2, 2022 | Z-0771-2023 | — | terminated | The stylet is longer than specified on the label |
| Mar 5, 2014 | Z-1441-2014 | — | terminated | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-). |
| Aug 29, 2012 | Z-0028-2013 | — | terminated | Sterility of the product may be compromised. |
| Feb 7, 2011 | Z-1575-2011 | — | terminated | There is a potential for the needle hubs to break during use. |
| Feb 7, 2011 | Z-1573-2011 | — | terminated | There is a potential for the needle hubs to break during use. |
| Feb 7, 2011 | Z-1576-2011 | — | terminated | There is a potential for the needle hubs to break during use. |
| Feb 7, 2011 | Z-1577-2011 | — | terminated | There is a potential for the needle hubs to break during use. |
| Feb 7, 2011 | Z-1574-2011 | — | terminated | There is a potential for the needle hubs to break during use. |
| Jan 12, 2011 | Z-2405-2011 | — | terminated | There have been complaints of the Drainage Bags leaking from the outlet and the inlet port. |
| May 19, 2010 | Z-2223-2010 | — | terminated | The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG. |
| Jun 19, 2009 | Z-1935-2009 | — | terminated | Two unsealed pouches were identified after product release, compromising product sterility. |
| Apr 6, 2009 | Z-1417-2009 | — | terminated | Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked. |
| Jul 23, 2007 | Z-0058-2008 | — | terminated | Sterility, inadequate -- Pathway may not be sterile as labeled. |
| Jan 19, 2007 | Z-0673-2007 | — | terminated | Pouches were not sealed prior to sterilization. |
| Aug 31, 2005 | Z-0124-06 | — | terminated | The vector selector has an electrical design flaw which prevents RV pacing. |
| Jun 6, 2005 | Z-0067-06 | — | terminated | The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use. |
| Jun 6, 2005 | Z-0066-06 | — | terminated | The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use. |
| Jun 6, 2005 | Z-0065-06 | — | terminated | The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use. |
| Feb 15, 2005 | Z-0697-05 | — | terminated | The stylet hub detaches from the stylet needle. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Remington Medical Markham Ontario · CA FEI 3001676837