Boston Scientific Radial Jaw 4 Biopsy Forceps 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 Corporation is recalling certain Radial Jaw 4 Standard Capacity 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 20, 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, medical-devices.
What Happened
Boston Scientific Corporation initiated a voluntary recall of specific Radial Jaw 4 biopsy forceps after identifying a potential breach in the sterile barrier of the device packaging. The recall is classified as Class II by the FDA.
Which Products Are Affected
The recall affects the following products distributed nationwide in the US and internationally:
- Radial Jaw 4 SC 240cm Box 20 (Outer Box UPN: M00513401; Inner Box UPN: M00513400; GTIN: 08714729777960; Lot Number: 38508541)
- Radial Jaw 4 SC 240cm Box 40 (Outer Box UPN: M00513402; Inner Box UPN: M00513400; GTIN: 08714729778028; Lot Numbers: 38517807)
- Radial Jaw 4 SC w/ Needle 240cm Box 20 (Outer Box UPN: M00513411; Inner Box UPN: M00513410; GTIN: 08714729777984; Lot Number: 38488064) A total of 5,020 units were distributed in the US, with 20,770 units distributed outside the US. The recall covers US Nationwide distribution including 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.
What You Should Do
The recalling firm initiated notification via letter. Customers should follow instructions provided in the notification for affected products.
Why This Matters
This Class II recall addresses a potential sterility issue with biopsy forceps used in medical procedures across the United States and internationally.
Source
FDA recall number Z-2838-2026. Event ID 99300. Report date 20260812.
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 (1,480 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 20, 2026.
Frequently Asked Questions
Common questions about this FDA recall.