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FDA Devices Verify with FDA Devices → Moderate Class II Terminated

The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).

Reported: July 13, 2016 Initiated: November 23, 2015 #Z-2121-2016 1252 total units

The recall

Zyto Technologies, Inc. issued this moderate-severity FDA Devices recall — ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due ….

Moderate
severity level
1252 total
units affected
Class II
classification
July 13, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2121-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2121-2016) was formally reported on July 13, 2016, with the manufacturer initiating the action on November 23, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Zyto Technologies, Inc. is listed as the recalling firm, operating out of Lindon, UT. Federal records indicate 1252 total units are affected.

The documented reason for this recall is: ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. Distribution data in the federal record shows the product reached: Nationwide. Canadian and other foreign consignees. No VA/govt/military.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Where this recall sits in the database

Severity2119858883High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.

Severity

Moderate

Units Affected

1252 total

Related Recalls

6

6 from same agency

Product Description

The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).

Reason for Recall

ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.

Details

Recalling Firm
Zyto Technologies, Inc.
Units Affected
1252 total
Distribution
Nationwide. Canadian and other foreign consignees. No VA/govt/military.
Location
Lindon, UT

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2121-2016
Date reported July 13, 2016
Date initiated November 23, 2015
Recalling firm Zyto Technologies, Inc.
Units affected 1252 total
Distribution Nationwide. Canadian and other foreign consignees. No VA/govt/military.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1252 total units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).. Recalled by Zyto Technologies, Inc.. Units affected: 1252 total.
Why was this product recalled?
ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2121-2016.
Where was the recalled product distributed?
Distribution: Nationwide. Canadian and other foreign consignees. No VA/govt/military..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2121-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page
  • U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
  • BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
  • BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
  • U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
  • IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
  • data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).