Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published June 30, 2026

Boston Scientific Radial Jaw 4 Biopsy Forceps: Packaging Sterile Barrier Risk

Boston Scientific recalls Radial Jaw 4 Large Capacity Biopsy Forceps with potential packaging breaches that could compromise sterility during medical procedures. Affected units include specific box sizes and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2839-2026Medical deviceBoston Scientific ›
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling certain Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile packaging. This could lead to contamination during medical procedures if the packaging is compromised. Read more at govinfonow.com/recall/314295-boston-scientific-radial-jaw-4-biopsy-forceps-packaging-sterile-barrier.

Source Summary by GovInfoNow · govinfonow.com/recall/314295-boston-scientific-radial-jaw-4-biopsy-forceps-packaging-sterile-barrier · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2839-2026

Cite this page

“Boston Scientific Radial Jaw 4 Biopsy Forceps: Packaging Sterile Barrier Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314295-boston-scientific-radial-jaw-4-biopsy-forceps-packaging-sterile-barrier. Based on FDA recall #Z-2839-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2839-2026%22&limit=1).

Boston Scientific Corporation voluntarily recalled Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of the device packaging, the FDA said on June 30, 2026.

How to tell if you have it

  • Radial Jaw 4 LC 240cm Box 20 (Outer Box UPN: M00513321; Inner Box UPN: M00513320; GTIN: 08714729648796; Lot Numbers: 38494988)
  • Radial Jaw 4 LC 240cm Box 40 (Outer Box UPN: M00513322; Inner Box UPN: M00513320; GTIN: 08714729648802; Lot Numbers: 38497139)
  • Radial Jaw 4 LC w/Needle 240cm Box 20 (Outer Box UPN: M00513331; Inner Box UPN: M00513330; GTIN: 08714729648819; Lot Numbers: 38509777)
  • Radial Jaw 4 LC w/Needle 240cm Box 40 (Outer Box UPN: M00513332; Inner Box UPN: M00513330; GTIN: 08714729648826; Lot Numbers: 38499451)
  • Radial Jaw 4 LC w/Needle 240cm Box 5 (Outer Box UPN: M00513333; Inner Box UPN: M00513330; GTIN: 08714729755494; Lot Number: 38519443)

The hazard

The hazard is a potential breach in the sterile barrier of the device packaging, according to the FDA.

Context

GovInfoNow's records show Boston Scientific Corporation has had 124 other recalls on record since June 1, 2017. Recent brand recalls include the Aug. 24, 2026 recall of Imager II Angiographic Catheters for tip fracture risk and the Aug. 6, 2026 recall of LUX-Dx Cardiac Monitor Systems for delayed AF burden alerts. Other recent recalls of similar products include the April 22, 2026 Boston Scientific Intracept Access Instruments Recall for risk of sterility breach and the June 12, 2026 Medline Ultrasonic Breast Pack Kits recall for risk of sterile packaging breach.

How to tell if you have this one

Check for the following: Radial Jaw 4 LC 240cm Box 20, Box 40, or Box 5 with specific outer and inner box UPNs listed. Lot numbers 38494988, 38497139, 38509777, 38499451, or 38519443 are also affected.

  • Brand
    Boston Scientific
  • Product
    Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • 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.
Recall numberProduct, codes & lots
Z-2838-2026Radial 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.; 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.
Z-2839-2026Radial 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.; 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.
Z-2840-2026Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.; Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094.
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Integrity

    Inspect the outer and inner boxes for any signs of damage or breach in the sterile packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 32 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Jun 30, 202612. FDA classified it Class II: Jul 31, 202623. Published in FDA’s Enforcement Report: Aug 12, 202634. Added to GovInfoNow: Aug 18, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2839-2026 (June 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2839-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA