Manus Medical, LLC
United Statesfrom the FDA registration address FDA establishment FEI 1121091
Manus Medical, LLC is a medical device manufacturer, with 592 devices listed in FDA GUDID (FDA Class II, I and III) and 33 FDA recalls as of 12 Nov 2026.
- Devices
- 592
- Registrations
- FDA
- FDA recalls
- 33
Registry facts
- Registries
- FDA GUDID 592
- Device classes
- FDA Class II 357
- FDA Class I 229
- FDA Class III 2
- FDA recalls
- Identifiers
- FDA FEI 1121091
What Manus Medical, LLC makes
Manus Medical, LLC produces single-use surgical supplies, including non-medicated and medicated general surgical procedure kits, surgical patient preparation kits, suture removal kits, bone marrow biopsy procedure kits, closed-wound drainage kits, surgical towels, and medicated wound dressing kits.
The company’s products are regulated under FDA’s 510(k) and pre-market approval (PMA) pathways, classified as Class I, Class II, and Class III devices, and are listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 592 devicesShowing 1-50 of 592
Company details
- FDA FEI number
- 1121091
- Address
- 4205 EUBANK ROAD, Henrico, VA, 23231
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 29
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 20 Dec 2019 Z-0863-2020 Class II Terminated A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.
2018
- 13 Aug 2018 Z-0240-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0241-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0242-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0243-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0244-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0245-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0246-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0247-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0248-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Show the 25 most recent of 33 recalls
2018
- 13 Aug 2018 Z-0249-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0250-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0251-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0252-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0253-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0254-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0255-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0256-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0257-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0258-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0259-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0260-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0261-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0262-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- 13 Aug 2018 Z-0263-2019 Class II Terminated Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Frequently asked questions
How many devices does Manus Medical, LLC have in the registry?
The registry currently lists 592 devices for Manus Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Manus Medical, LLC's devices?
Among its 50 most recently registered devices, Manus Medical, LLC has devices listed in FDA GUDID (50 devices).
What risk classes do Manus Medical, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Manus Medical, LLC's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Manus Medical, LLC?
FDA recall records list 33 recalls initiated by Manus Medical, LLC, the most recent initiated on 20 Dec 2019. 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 Manus Medical, LLC in the registry?
The most recently registered devices listed for Manus Medical, LLC include Manus Medical, LLC DULY-20400-01, Custom Healthcare Systems of VA, LLC CLT-19914, Custom Healthcare Systems Inc. B9-16999B and Custom Healthcare Systems Inc. MM-13713.