Boston Scientific Corporation recalls Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:…
Reason for recall
Potential for breach in sterile barrier of device packaging.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.
Lot / code information
- GTIN
- 08714729648796
- Lot #
- 38494988. 2. Outer Box UPN: M00513322; Inner Box UPN: M00513320
- GTIN
- 08714729648802
- Lot #
- 38497139. 3. Outer Box UPN: M00513331; Inner Box UPN: M00513330
- GTIN
- 08714729648819
- Lot #
- 38509777. 4. Outer Box UPN: M00513332; Inner Box UPN: M00513330
- GTIN
- 08714729648826
- Lot #
- 38499451. 5. Outer Box UPN: M00513333; Inner Box UPN: M00513330
- GTIN
- 08714729755494
- Lot #
- 38519443
What the firm is doing
Firm began notifying consignees via FedEx Priority Overnight on June 30, 2026. Customers were instructed to check their inventory, remove affected product, and return it to Boston Scientific. Customers should immediately stop further use or distribution of the product.
DistributionShow detailsHide
US Nationwide distribution including in 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 pending.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2839-2026
- FDA device classification · FCLOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1075The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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