FDA Announces Recall of I.T.S. DUL and UOL Systems
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 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, Devices.
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 ↗
Related FDA Recalls
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.
Similar body length
Nearest notices by article body length (1,624 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.