DONJOY IceMan CLASSIC CUBE Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

DJO, LLC recalls 596 units of the DONJOY IceMan CLASSIC CUBE (model 11-0494) due to a broken connector that may interrupt cold therapy.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.

What Happened

DJO, LLC is recalling the IceMan CLASSIC CUBE cold therapy unit because a broken connector may result in a temporary interruption of prescribed cold therapy.

Which Products Are Affected

Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 GTIN: 00888912003100 Lot Codes: 146894, 146895, 146856, 146857 Quantity: 596 units Distribution: U.S. nationwide (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, WV) and Canada.

What You Should Do

Consumers should contact DJO, LLC regarding the recall. Specific return or refund instructions will be provided by the firm.

Why This Matters

The recall affects a medical device used to reduce pain and swelling during rehabilitation, with potential temporary disruption of therapy for users.

Source

FDA recall number Z-2134-2026, event ID 98638.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
DJO, LLC recalls 596 units of the DONJOY IceMan CLASSIC CUBE (model 11-0494) due to a broken connector that may interrupt cold therapy.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.