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Retractable Technologies, Inc.

United States·US-MF-000031781

Last updated September 17, 2026

About

Retractable Technologies delivers automated retractable syringe & needle safety solutions that reduce needlestick injuries, reduce waste, & protect healthcare workers.

From the manufacturer's own website, in their original language. Source

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.

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 Retractable Technologies, Inc. primarily manufacture?

Retractable Technologies, Inc. specializes in single-use hypodermic syringes and needles, including metered-delivery and general-purpose varieties. Their portfolio also includes needle guards, blood collection sets, peripheral vascular catheters, and integrated blood collection tube holders with retractable needles. Many of their devices feature retractable needle designs to enhance post-use safety.

Where is Retractable Technologies, Inc. based, and what markets do their devices serve?

Retractable Technologies, Inc. is headquartered in the United States. Their devices are designed for global use, with regulatory listings in both the U.S. and EU markets. This includes compliance with the FDA’s 510(k) pathway and UDI system in the U.S., as well as registration in the EU’s eudamed database, ensuring adherence to medical device directives in both regions.

Which regulatory registries list Retractable Technologies, Inc.’s devices?

Retractable Technologies, Inc.’s devices are listed in three key regulatory databases: the FDA’s 510(k) clearance registry, the FDA’s Unique Device Identification (UDI) system, and the EU’s eudamed database. These registries reflect the company’s compliance with U.S. and European medical device regulations, though individual device authorisations depend on their classification and specific regulatory pathways.

How are Retractable Technologies, Inc.’s devices classified under FDA regulations?

Retractable Technologies, Inc.’s devices fall under FDA Class II, Class IIa, and Class IIb classifications. Class II devices typically require special controls beyond general controls to ensure their safety and effectiveness, while Class IIa and IIb distinctions may reflect varying levels of risk or regulatory oversight. These classifications determine the authorisation pathway, such as the 510(k) process, which demonstrates substantial equivalence to a predicate device.

What distinguishes Retractable Technologies, Inc.’s retractable needle devices from standard hypodermic needles?

Retractable Technologies, Inc.’s retractable needle devices, such as those under the VanishPoint® and EasyPoint® brands, are designed with an automatic mechanism that retracts the needle into the syringe or holder after use. This feature reduces the risk of needle-stick injuries, a common hazard with traditional hypodermic needles, while maintaining functionality for tasks like injections, blood collection, or catheter insertion. The retractable design aligns with safety-focused medical device trends.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
511, Lobo Lane, Little Elm, United States
Website
retractable.com
LinkedIn
linkedin.com/company/retractable-technologies-inc
Facebook
facebook.com/RetractableTechnologies
Email
[email protected]
Phone
972-294-1010
PRRC Contact
Michele Larios
EUDAMED SRN
US-MF-000031781
FDA FEI Number
1000306068
DUNS Number
—

Catalogue (104)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
VanishPoint® 24121
FDA UDI
Class IIActive
VanishPoint® 15291
FDA UDI
Class IIActive
EasyPoint® 82091
FDA UDI
Class IIActive
VanishPoint® 24111
FDA UDI
Class IIActive
VanishPoint® 10561
FDA UDI
Class IIActive
VanishPoint® 10631
FDA UDI
Class IIActive
VanishPoint® 10581
FDA UDI
Class IIActive
VanishPoint® 10541
FDA UDI
Class IIActive
VanishPoint® 11071
FDA UDI
Class IIActive
VanishPoint® 10361
FDA UDI
Class IIActive
VanishPoint® 13011
FDA UDI
Class IIActive
VanishPoint® 15371
FDA UDI
Class IIActive
VanishPoint® 10271
FDA UDI
Class IIActive
VanishPoint® 15271
FDA UDI
Class IIActive
VanishPoint® 10281
FDA UDI
Class IIActive
VanishPoint® 24131
FDA UDI
Class IIActive
VanishPoint® 10571
FDA UDI
Class IIActive
VanishPoint® 11041
FDA UDI
Class IIActive
VanishPoint® 10171
FDA UDI
Class IIActive
VanishPoint® 35221
FDA UDI
Class IIActive
Patient Safe® 50501
FDA UDI
Class IIActive
VanishPoint® 31741
FDA UDI
Class IIActive
EasyPoint® 85011
FDA UDI
Class IIActive
VanishPoint® 10151
FDA UDI
Class IIActive
VanishPoint® 10531
FDA UDI
Class IIActive
VanishPoint® 11081
FDA UDI
Class IIActive
VanishPoint® 10511
FDA UDI
Class IIActive
VanishPoint® 15391
FDA UDI
Class IIActive
VanishPoint® 10431
FDA UDI
Class IIActive
VanishPoint® 10231
FDA UDI
Class IIActive
VanishPoint® 90136
FDA UDI
Class IIActive
VanishPoint® 10321
FDA UDI
Class IIActive
VanishPoint® 24021
FDA UDI
Class IIActive
EasyPoint® 82031
FDA UDI
Class IIActive
VanishPoint® 22711
FDA UDI
Class IIActive
VanishPoint® 31641
FDA UDI
Class IIActive
VanishPoint® 31331
FDA UDI
Class IIActive
VanishPoint® 10251
FDA UDI
Class IIActive
VanishPoint® 10331
FDA UDI
Class IIActive
EasyPoint® 85081
FDA UDI
Class IIActive
VanishPoint® 24331
FDA UDI
Class IIActive
Patient Safe® 53001
FDA UDI
Class IIActive
EasyPoint® 85071
FDA UDI
Class IIActive
Anti-Stick Syringe With Integral Hypodermic Needle Vanishpoint Syringe K970803
FDA 510(k)
Class IIActive
Patient Safe Luer Cap K101708
FDA 510(k)
Class IIActive
EasyPoint Blood Collection Plus K202325
FDA 510(k)
Class IIActive
Anti-Stick Syringe With Integral Hypodermic Needle/Vanishpoint Syringe K973301
FDA 510(k)
Class IIActive
Pop-N-Lok Syringe K946219
FDA 510(k)
Class IIActive
Blood Collection Tube Holder Vanishpoint Tube Holder/Small Tube Adapter K971763
FDA 510(k)
Class IIActive
VanishPoint IV Catheter 31221
EUDAMEDFDA UDI
Class IIbActive

Related Companies

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Retractable Technologies, Inc. has one recall record initiated on February 5, 2024, with both open and classified statuses recorded. The reason stated involves the potential detachment of the needle cannula from the needle holder during use.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Feb 5, 2024Z-1293-2024—open, classified

The needle cannula of a retractable needle may detach from the needle holder in the patient.