FDA recall, , Moderate risk
Boston Scientific Radial Jaw 4 Biopsy Forceps
Radial Jaw 4 Standard Capacity Biopsy Forceps may have a breach in the sterile barrier of their packaging.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation of Marlborough, Massachusetts, began a recall on June 30, 2026, for Radial Jaw 4 Jumbo, Large Capacity, and Standard Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging. The FDA added the recall to its Enforcement Report and classified it on July 31, 2026, with distribution in the US nationwide and internationally pending.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Radial Jaw 4 Jumbo Biopsy Forceps
- UDI-DI
- 08714729761914
- 38496094
Radial Jaw 4 Large Capacity Biopsy Forceps
- UDI-DI
- 08714729648796
- 38494988
- 08714729648802
- 38497139
- 08714729648819
- 38509777
- 08714729648826
- 38499451
- 08714729755494
- 38519443
- Lot code
- M00513322
- M00513331
- M00513332
- M00513333
Radial Jaw 4 Standard Capacity Biopsy Forceps
- UDI-DI
- 08714729777960
- 38508541
- 08714729778028
- 38517807
- 08714729777984
- 38488064
- Lot code
- M00513402
- M00513400
- M00513411
- M00513410
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, PR, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and International distribution pending.
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99300
- Recall numbers
- Z-2838-2026 to Z-2840-2026
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
