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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97146

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 22, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
LTS Therapy Systems, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

Z-2196-2025
Recall number
Z-2196-2025
Initiated
May 22, 2025
Classification
Class II
Status
Ongoing
Recalling firm
LTS Therapy Systems, LLC
Quantity
80928 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

Code information

Lot Code: UDI-DI: (01) 10815611020005 UDI-PI: (10) 4283 Lot numbers: 4283-1, 4283-2, 4283-3, 4283-4

Distribution pattern

US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.

device · product 2 of 2

IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

Z-2197-2025
Recall number
Z-2197-2025
Initiated
May 22, 2025
Classification
Class II
Status
Ongoing
Recalling firm
LTS Therapy Systems, LLC
Quantity
63936 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

Code information

Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3

Distribution pattern

US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.