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Zyno Medical LLC.

Last updated September 17, 2026

Information

Country: US
Address: 177 Pine St, Natick, MA, 01760
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3006575795
DUNS Number: —

Catalogue (47)

Device	Model / Reference	Registries	Class	Status
Zyno	B2-70071-P	FDA UDI	Class II	Active
Zyno	A2-80071-PF	FDA UDI	Class II	Active
Zyno	B2-70070	FDA UDI	Class II	Active
Z-800	Z-800	FDA UDI	Class II	Active
Zyno	BX-70072	FDA UDI	Class II	Active
Zyno	AX-80071-DF	FDA UDI	Class II	Active
Nimbus	Nimbus	FDA UDI	Class II	Unknown
Zyno	A2-80075	FDA UDI	Class II	Active
Zyno	B2-70072	FDA UDI	Class II	Active
Zyno	BX-70071-DF-120	FDA UDI	Class II	Active
Zyno	AX-80071-P	FDA UDI	Class II	Active
Zyno	B2-70071-D	FDA UDI	Class II	Active
Zyno	AX-80071-D	FDA UDI	Class II	Active
Zyno	B2-70072-F	FDA UDI	Class II	Active
Zyno	A2-80071-P	FDA UDI	Class II	Active
Z-800f	Z-800F	FDA UDI	Class II	Active
Zyno	B2-70071-DF	FDA UDI	Class II	Active
Z-800w	Z-800W	FDA UDI	Class II	Active
Zyno	AX-80075	FDA UDI	Class II	Active
Zyno	BX-70071-DF	FDA UDI	Class II	Active
Zyno	AX-80072	FDA UDI	Class II	Active
Zyno	AX-80071-DF-120	FDA UDI	Class II	Active
Zyno	A2-80071-D	FDA UDI	Class II	Active
Zyno	AX-80072-F	FDA UDI	Class II	Active
Zyno	FE04	FDA UDI	Class II	Active
Zyno	BX-70071-P	FDA UDI	Class II	Active
Zyno	A2-80070	FDA UDI	Class II	Active
Zyno	AA-80075	FDA UDI	Class II	Active
Zyno	AX-80070	FDA UDI	Class II	Active
Zyno	A2-80071-DF	FDA UDI	Class II	Active
Zyno	BX-70071-D	FDA UDI	Class II	Active
Zyno	A2-80072-F	FDA UDI	Class II	Active
Zyno	A2-80072	FDA UDI	Class II	Active
Zyno	BX-70070	FDA UDI	Class II	Active
Zyno	AX-80071-PF	FDA UDI	Class II	Active
Zyno	A2-80071-DF120	FDA UDI	Class II	Active
Zyno	B2-70071-DF120	FDA UDI	Class II	Active
Zyno	BX-70072-F	FDA UDI	Class II	Active
Zyno	FE01	FDA UDI	Class II	Active
Z-800wf	Z-800WF	FDA UDI	Class II	Active
Z-800 Infusion System	K130690	FDA 510(k)	Class II	Active
Zyno Medical Administration Set	K120685	FDA 510(k)	Class II	Active
Zyno Medical Administration Set	K132841	FDA 510(k)	Class II	Active
Halo Ambulatory Infusion System	K140783	FDA 510(k)	Class II	Active
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)	K153193	FDA 510(k)	Class II	Active
Z-800 Volumetric Infusion Pump	K071545	FDA 510(k)	Class II	Active
Zyno Z-800 Infusion System Model Z-800	K100705	FDA 510(k)	Class II	Active

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FDA Recalls (16)

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

Date	Recall No.	Class	Status	Reason
May 7, 2025	Z-1868-2025	—	open, classified	Unreleased software versions were installed on distributed devices without verification or validation.
May 7, 2025	Z-1867-2025	—	open, classified	Unreleased software versions were installed on distributed devices without verification or validation.
May 7, 2025	Z-1866-2025	—	open, classified	Unreleased software versions were installed on distributed devices without verification or validation.
May 7, 2025	Z-1865-2025	—	open, classified	Unreleased software versions were installed on distributed devices without verification or validation.
Oct 18, 2024	Z-0506-2025	—	open, classified	Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Sep 30, 2024	Z-0523-2025	—	open, classified	For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
Sep 13, 2024	Z-0005-2025	—	open, classified	There is a defect in the air-in-line software algorithm.
Jun 4, 2024	Z-2263-2024	—	open, classified	Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.
Dec 20, 2023	Z-1183-2024	—	open, classified	When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
May 29, 2019	Z-2059-2019	—	terminated	Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
May 29, 2019	Z-2058-2019	—	terminated	Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
Jul 29, 2016	Z-2896-2016	—	terminated	Administration Set potential filter leaking
Jul 29, 2016	Z-2895-2016	—	terminated	Administration Set potential filter leaking
Jul 29, 2016	Z-2894-2016	—	terminated	Administration Set potential filter leaking
Jul 29, 2016	Z-2893-2016	—	terminated	Administration Set potential filter leaking
Jun 13, 2011	Z-1024-2013	—	terminated	Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump