Boston Scientific Orca Valves Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific is recalling 9,750 units of Orca Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 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
Boston Scientific Corporation is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Which Products Are Affected
The recall affects Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50. The product is intended to control the air/water function on an endoscope during a GI endoscopic procedure. Affected units total 9,750 and are distributed nationwide in the United States. Specific lot details include GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029. The recall number is Z-2413-2026.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters
The Class II recall involves a device malfunction that could lead to temporary or reversible adverse health consequences.
Source
FDA recall Z-2413-2026, report date 20260617.
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 (993 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.