Boston Scientific Radial Jaw 4 Jumbo Biopsy Forceps Recall

Source: FDA · United States

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 Corporation is recalling certain Radial Jaw 4 Jumbo Biopsy Forceps due to a potential breach in the sterile barrier of the device packaging.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 18, 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 initiated a voluntary recall of Radial Jaw 4 Jumbo Biopsy Forceps due to the potential for a breach in the sterile barrier of device packaging.

Which Products Are Affected

The recall involves Radial Jaw 4 Jumbo 240cm Box 5 with Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094. A total of 5,020 units were distributed in the US, with an additional 20,770 units distributed outside the US. The recall covers US Nationwide distribution including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and international distribution.

What You Should Do

Consumers should contact Boston Scientific Corporation for further information regarding the recall.

Why This Matters

This Class II recall addresses a defect that could lead to temporary or reversible adverse health consequences if the sterile barrier is compromised.

Source

FDA recall number Z-2840-2026. Event ID: 99300. Recalling firm: Boston Scientific Corporation, Marlborough, MA.

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Boston Scientific Corporation is recalling certain Radial Jaw 4 Jumbo Biopsy Forceps due to a potential breach in the sterile barrier of the device packaging.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.