Recall Register

Food, drugs, devices › Firms

Zeus Scientific, Inc.

FDA recalling firm · 3 enforcement events · 4 product records · 2019–2023 · NJ

Zeus Scientific, Inc. has 3 FDA enforcement events on this register (4 product records) between 2019 and 2023: 3 device; the busiest year was 2019 with 2.

0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
31 Oct 2023ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701MDeviceClass II2Ongoing
12 Aug 2019ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.DeviceClass II1Terminated
22 Jul 2019Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS…DeviceClass II1Terminated

By type and class

Device3
Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

19
20
21
22
23
24
25
26
Enforcement events for Zeus Scientific, Inc. by year initiated.

Questions and answers

How many FDA recalls has Zeus Scientific, Inc. had?

3 enforcement events (4 product records) on this register, 2019–2023: 3 device.

Are any Zeus Scientific, Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Zeus Scientific, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.