Medline Oral Restoration Kits Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries is recalling certain MEDLINE Medical Procedure Kits labeled ORAL RESTORATION due to catheter performance issues identified in internal review.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 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, Devices.
What Happened
Medline Industries, LP initiated a voluntary recall after an internal review found representative samples of the kits did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Which Products Are Affected
The recall affects MEDLINE Medical Procedure Kits labeled as ORAL RESTORATION, Medline Kit Number/SKU DYNJ86253A. Affected lot numbers are 25KBC063 and 25JBO955. UDI/DI codes are 10198459556654 (each) and 40198459556655 (case). Zero units are reported in the recall quantity. Distribution was nationwide in the United States and to the countries AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, and VI.
What You Should Do
Consumers with questions should contact the recalling firm using the notification methods provided in the recall announcement.
Why This Matters
This Class II recall involves devices that may cause temporary or medically reversible adverse health consequences.
Source
FDA recall number Z-2490-2026. 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 (1,200 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.