CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Radial Jaw 4 Large Capacity Biopsy Forceps recalled by Boston Scientific
Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN, distributed nationwide in the US. The recall was initiated on 30 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2839-2026
- FDA event ID
- 99300
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2026
- FDA classified
- 31 Jul 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 30 Jun 2026 | Recall initiated by company | |
| 31 Jul 2026 | Classified by FDA | +31 days |
| 12 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for breach in sterile barrier of device packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyMassachusettsMarylandMaineMinnesotaMissouriMississippiMontanaNorth CarolinaNew Jersey
Questions about this recall
Why was it recalled?
Potential for breach in sterile barrier of device packaging.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99300This product is part of a recall event; the main page for the event is Radial Jaw 4 Jumbo Biopsy Forceps recalled by Boston Scientific.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Radial Jaw 4 Jumbo Biopsy Forceps recalled by Boston Scientific | Boston Scientific | Sterility | Nationwide | |
| CLASS II | Radial Jaw 4 Standard Capacity Biopsy Forceps recalled | Boston Scientific | Sterility | Nationwide |
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