Grace Medical TITANIUM/FLUOROPLASTIC PISTON Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Grace Medical, Inc. is recalling 7 units of its TITANIUM/FLUOROPLASTIC PISTON due to incorrect functional length on device labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 10, 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
Grace Medical, Inc. initiated a voluntary recall due to incorrect functional length on device labeling.
Which Products Are Affected
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L, Model/Catalog Number: 409-375, Lot Number: 122927, UDI: (01)00844505000772(10)122927(17)310301. A total of 7 units were distributed nationwide in the state of MD.
What You Should Do
The recall is ongoing and was initiated by letter. Contact Grace Medical, Inc. for additional information.
Why This Matters
This Class II recall involves a device labeling error affecting a small number of units distributed in the United States.
Source
FDA recall number Z-2308-2026 (report date 20260610).
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 (705 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.