Boston Scientific Radial Jaw 4 Biopsy Forceps Recall
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Boston Scientific Corporation is recalling certain Radial Jaw 4 Large 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 19, 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 specific Radial Jaw 4 Large Capacity Biopsy Forceps devices due to the potential for a breach in the sterile barrier of the device packaging. The recall is classified as Class II by the FDA.
Which Products Are Affected The affected products are:
- Radial Jaw 4 LC 240cm Box 20 (Outer Box UPN: M00513321; Inner Box UPN: M00513320; GTIN: 08714729648796; Lot: 38494988)
- Radial Jaw 4 LC 240cm Box 40 (Outer Box UPN: M00513322; Inner Box UPN: M00513320; GTIN: 08714729648802; Lot: 38497139)
- Radial Jaw 4 LC w/Needle 240cm Box 20 (Outer Box UPN: M00513331; Inner Box UPN: M00513330; GTIN: 08714729648819; Lot: 38509777)
- Radial Jaw 4 LC w/Needle 240cm Box 40 (Outer Box UPN: M00513332; Inner Box UPN: M00513330; GTIN: 08714729648826; Lot: 38499451)
- Radial Jaw 4 LC w/Needle 240cm Box 5 (Outer Box UPN: M00513333; Inner Box UPN: M00513330; GTIN: 08714729755494; Lot: 38519443) A total of 5,020 units were distributed in the US, with an additional 20,770 units distributed outside the US. Distribution was nationwide in the United States, 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 The recall was initiated voluntarily by Boston Scientific Corporation via letter notification. Consumers with questions should refer to the recalling firm contact details provided in the official FDA recall notice.
Why This Matters A breach in sterile barrier packaging could compromise device sterility for these biopsy forceps distributed across the US and internationally.
Source FDA recall Z-2839-2026, https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,776 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.