Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box
Summary
The FDA issued a Class II for Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions an by Boston Scientific Corporation. Reason: Potential for breach in sterile barrier of device packaging..
Details
Source
Device Recall
External ID
Z-2838-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
Lot/Code Info: 1. Outer Box UPN: M00513401. Inner Box UPN: M00513400. GTIN: 08714729777960. Lot Number: 38508541. 2. Outer Box UPN: M00513402. Inner Box UPN: M00513400. GTIN: 08714729778028. Lot Numbers: 38517807. 3. Outer Box UPN: M00513411. Inner Box UPN: M00513410. GTIN: 08714729777984. Lot Number: 38488064.
Quantity Affected: 5,020 (US); 20,770 (OUS)
Reason for Recall
Potential for breach in sterile barrier of device packaging.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-30
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Boston Scientific Corporation has 415 FDA actions in our database, including 348 recalls and 67 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 415 FDA actions in our database, including 348 recalls and 67 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2838-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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