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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94120

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

Open FDA event record

Event summary

Timeline bucket
February 21, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Bruder Healthcare Company, 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

9 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 9

Thermalon Eye Compress, Item Number 2434

Z-1359-2024
Recall number
Z-1359-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
2400 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533243427, Lot Codes: M056410

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 2 of 9

Thermalon Sinus Compress (French), Item Number 24332F

Z-1360-2024
Recall number
Z-1360-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
2160 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533243328, Lot Numbers: M053600, M053340

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 3 of 9

Thermalon Sinus Compress, Item Number 24332

Z-1361-2024
Recall number
Z-1361-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
1416 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533243328, Lot Numbers: M053160, M053570

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 4 of 9

Thermalon Back Wrap, Item Number 24312

Z-1362-2024
Recall number
Z-1362-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
193 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533243120, Lot Numbers: M053210, M053580, M055910

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 5 of 9

Thermalon Neck Wrap, Item Number 24322

Z-1363-2024
Recall number
Z-1363-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
471 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533243229, Lot Numbers: M053560, M053140

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 6 of 9

Thermalon Heating Pad, Item Number 24002

Z-1364-2024
Recall number
Z-1364-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
1656 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533240020, Lot Numbers: M055930

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 7 of 9

Thermalon Stye Compress, Item Number 24352

Z-1365-2024
Recall number
Z-1365-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
24 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533243526, Lot Numbers: M058520

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 8 of 9

MediBeads Neck Wrap, Item Number 34320

Z-1366-2024
Recall number
Z-1366-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
430 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533343202, Lot Numbers: M053300

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 9 of 9

MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R

Z-1367-2024
Recall number
Z-1367-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
585 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
growth of mold

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

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

Code information

UPC 041533341208, Lot Numbers: M053590, M053280

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.