Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98638

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

Open FDA event record

Event summary

Timeline bucket
March 19, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DJO, 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

4 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 4

Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no

Z-2134-2026
Recall number
Z-2134-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Recalling firm
DJO, LLC
Quantity
596

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Code information

Model/Catalog Number: 11-0494 Lot Code: Lots: 146894, 146895, 146856, 146857 GTIN: 00888912003100

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.

device · product 2 of 4

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

Z-2135-2026
Recall number
Z-2135-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Recalling firm
DJO, LLC
Quantity
1412

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Code information

Model/Catalog Number: 11-1422 Lot Code: Lot: 101325, 101425 GTIN: 00888912005869

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.

device · product 3 of 4

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

Z-2136-2026
Recall number
Z-2136-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Recalling firm
DJO, LLC
Quantity
480

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Code information

Model/Catalog Number: 11-1424 Lot Code: Lot: 110525 GTIN: 00888912017305

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.

device · product 4 of 4

Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

Z-2137-2026
Recall number
Z-2137-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Recalling firm
DJO, LLC
Quantity
96

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Code information

Model/Catalog Number: 11-9099 Lot Code: Lot: 110525 GTIN: 00888912000376

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.