DONJOY IceMan CLASSIC CUBE Recall

Source: FDA · United States

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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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 →

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.