Z-2839-2026Class II

Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm...

Name: Z-2839-2026 Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm...
Creator: Boston Scientific Corporation
Published: 2026-06-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-06-30 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of 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... on 2026-06-30. FDA classified it as Class II and gives the reason as "Potential for breach in sterile barrier of device packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2839-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-30
Posted: 2026-07-31
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: FCL Forceps, Biopsy, Non-Electric
Reason for recall: Potential for breach in sterile barrier of device packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 5,020 (US); 20,770 (OUS)
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.
Product codes and lots: 1. Outer Box UPN: M00513321; Inner Box UPN: M00513320. GTIN: 08714729648796. Lot Numbers: 38494988. 2. Outer Box UPN: M00513322; Inner Box UPN: M00513320. GTIN: 08714729648802. Lot Numbers: 38497139. 3. Outer Box UPN: M00513331; Inner Box UPN: M00513330. GTIN: 08714729648819. Lot Numbers: 38509777. 4. Outer Box UPN: M00513332; Inner Box UPN: M00513330. GTIN: 08714729648826. Lot Numbers: 38499451. 5. Outer Box UPN: M00513333; Inner Box UPN: M00513330. GTIN: 08714729755494. Lot Number: 38519443.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2839-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2838-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31
Z-2839-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31
Z-2840-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31

Product code FCL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)