Zyno Medical recalls

Zyno Medical has 16 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 18 Jun 2025. 9 are still ongoing. The most frequent reason is device malfunction.

Total recalls16since 2013

Last 12 months0reported

Class I531% of total

Ongoing9latest 18 Jun 2025

Recalls per month, last 24 months

click a bar for that month

1Nov '24 1 0 0Feb 0 0 0May 4 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 5 31%Class II 10 63%Class III 1 6%

Why zyno medical is recalled

Product types

By year

2025425%
2024531%
2019213%
2016425%
201316%

Ongoing zyno medical recalls

9 active

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025Device	CLASS I	Z-800F Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800W Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800WF Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS III	Z-800 Infusion System Z-800WF recalled by Zyno Medical	Zyno Medical	Device Malfunction	8 states
27 Nov 2024Device	CLASS II	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Packaging Defects	MA

All zyno medical recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025Device	CLASS I	Z-800F Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800W Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800WF Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
18 Jun 2025Device	CLASS I	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS III	Z-800 Infusion System Z-800WF recalled by Zyno Medical	Zyno Medical	Device Malfunction	8 states
27 Nov 2024Device	CLASS II	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Packaging Defects	MA
16 Oct 2024Device	CLASS I	Z-800 Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
10 Jul 2024Device	CLASS II	Z800F, and Z800WF Infusion Pumps recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide
6 Mar 2024Device	CLASS II	Z800 Large Volume Infusion Pumps -Intended to provide recalled	Zyno Medical	Device Malfunction	Nationwide
31 Jul 2019Device	CLASS II	Administration Set -105"Admin Set 20DP, W/2 Y Site recalled	Zyno Medical	Other	MA
31 Jul 2019Device	CLASS II	Administration Set -105"Admin Set 20DP W/Filter 2YSITES recalled	Zyno Medical	Other	MA
5 Oct 2016Device	CLASS II	Administration Set, Sterile recalled by Zyno Medical	Zyno Medical	Packaging Defects	Nationwide
5 Oct 2016Device	CLASS II	Administration Set, Sterile recalled by Zyno Medical	Zyno Medical	Packaging Defects	Nationwide
5 Oct 2016Device	CLASS II	Administration Set Sterile recalled by Zyno Medical	Zyno Medical	Packaging Defects	Nationwide
5 Oct 2016Device	CLASS II	Administration Set, Sterile recalled by Zyno Medical	Zyno Medical	Packaging Defects	Nationwide
10 Apr 2013Device	CLASS II	Z-800 Volumetric Infusion System recalled by Zyno Medical	Zyno Medical	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.