FDA Announces Recall of I.T.S. DUL and UOL Systems
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The FDA is recalling 120 units of I.T.S. medical devices due to updated MRI safety testing showing higher temperature increases than previously indicated.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 8, 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 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.
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What Happened
The recall was initiated because updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than what was previously reflected in the Instructions for Use (IFU).
Which Products Are Affected
The affected products are the I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System. Specific items include: 1. I.T.S. DUL System, Distal Ulna Plate with article numbers 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, and 21235-4. 2. I.T.S. UOL System, Ulna Osteotomy Plate with article number 21231-6. 3. UOL System, Cancellous Screw, Locking with article numbers 37302-18 and 37302-20. The recall involves 120 units distributed nationwide in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, and W. Corresponding lot numbers are: For article 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), and others as listed in the source data. The official recall number is Z-1604-2026.
What You Should Do
Consumers should follow the initial firm notification, which was sent via E-mail, and contact the recalling firm, I.T.S. GmbH at Autal 28, Lasnitzhohe, Austria, for information on returns or refunds related to this voluntary recall.
Why This Matters
This recall affects 120 units of medical devices used in procedures, potentially impacting patient safety during MRI scans due to inaccurate safety information in the IFU.
Source
This information is from the FDA recall with number Z-1604-2026. Attribution: FDA (https://www.fda.gov)
Original source: FDA Official Notice ↗
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