MEDLINE 111 Gravity Set Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
BD Switzerland SARL recalls 50 units of MEDLINE 111 Gravity Set after an engineering sample labeled 'Not for Human Use' was shipped to Illinois.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references Illinois. 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
Due to an engineering sample labeled "Not for Human Use" being inadvertently shipped to the U.S. market.
Which Products Are Affected
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555, Catalog Number: SAM2461, Lot Number: 25X445. 50 devices distributed in Illinois.
What You Should Do
No specific consumer actions are provided in the recall notice.
Why This Matters
The recalled devices were not intended for human use.
Source
FDA recall number Z-2654-2026, Class II, initiated 20260604 by BD SWITZERLAND SARL.
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 (555 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.