Retractable Technologies, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000031781 FEI 1000306068
Retractable Technologies, Inc. is a medical device manufacturer based in the United States, with 106 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa and IIb) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 106
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 98
- EUDAMED 64
- FDA 510(k) 6
- Device classes
- FDA Class II 99
- EU Class IIa 5
- EU Class IIb 2
- Top EMDN categories
- FDA recalls
- Sites and related companies
- MDSS GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000031781
- FDA FEI 1000306068
- DUNS 838024255
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MDSS GmbHDE
What Retractable Technologies, Inc. makes
Retractable Technologies, Inc. manufactures single-use hypodermic syringes and needles, including metered-delivery and general-purpose designs, along with needle guards and blood collection systems. Their portfolio includes peripheral vascular catheters, blood collection sets, and integrated tube holders with retractable needles. The company also produces retractable needle devices under various trade names, designed for safe post-use disposal.
The company’s devices are classified under FDA regulations as Class II, Class IIa, and Class IIb, with corresponding authorisations through the 510(k) pathway and the FDA’s Unique Device Identification (UDI) system. Their products are also registered in the EU’s eudamed database, ensuring compliance with medical device directives in both the United States and European markets. The manufacturer is based in the United States.
Catalogue
Search and filter all 106 devicesShowing 1-50 of 106
Company details
- EUDAMED SRN
- US-MF-000031781
- FDA FEI number
- 1000306068
- DUNS number
- 838024255
- EUDAMED status
- Active
- EUDAMED registered name
- Retractable Technologies, Inc.
- Registered address
- 511, Lobo Lane, 75068, Little Elm, United States
- Website
- retractable.com
- Phone
- 972-294-1010
- PRRC contact
- Michele Larios
FDA recalls
FDA recall records list 1 recall initiated by Retractable Technologies, Inc., initiated on 2024-02-05. By recorded status: 1 ongoing. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 5 Feb 2024 Z-1293-2024 Class II Ongoing The needle cannula of a retractable needle may detach from the needle holder in the patient.
Full distribution text
- 5 Feb 2024 Z-1293-2024 Class II Ongoing The needle cannula of a retractable needle may detach from the needle holder in the patient.
From the company website
Retractable Technologies delivers automated retractable syringe & needle safety solutions that reduce needlestick injuries, reduce waste, & protect healthcare workers.
Frequently asked questions
How many devices does Retractable Technologies, Inc. have in the registry?
The registry currently lists 106 devices for Retractable Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Retractable Technologies, Inc.'s devices?
Among its 50 most recently registered devices, Retractable Technologies, Inc. has devices listed in EUDAMED (30 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Retractable Technologies, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Retractable Technologies, Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Retractable Technologies, Inc.?
FDA recall records list 1 recall initiated by Retractable Technologies, Inc., the most recent initiated on 5 Feb 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Retractable Technologies, Inc. in the registry?
The most recently registered devices listed for Retractable Technologies, Inc. include VanishPoint Syringe, VanishPoint® 10154, EasyPoint® 82211 and VanishPoint® 10301.