FDAClass II · Medical device · Recall Z-2668-2026 · Recalled July 8, 2026

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall — Bard Access Systems, Inc.

Agency report date: July 8, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code
Company / brand: Bard Access Systems
Lot / serial / date codes: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 Lot Number: REKY3390 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 Lot Numbers: REKY3393 REJZ0942 REJZ0943
Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.

Agency product description and boundaries

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2668-2026
Brand: All Bard Access Systems recalls
Classification: Class II
Units affected: 11,990
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall status

Companies & origin

Recalling firm location: Salt Lake City, UT, United States
Firm address: 605 N 5600 W, N/A, 84116-3738

Identifying details (verbatim from the notice)

Product codes / lots: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 Lot Number: REKY3390 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 Lot Numbers: REKY3393 REJZ0942 REJZ0943
Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.
Firm notified the public via: Letter
FDA event ID: 99096
Recall initiated: May 21, 2026
FDA classified: July 2, 2026
FDA report date: July 8, 2026

More Bard Access Systems recalls

DuoGlide Short-Term Straight Dialysis Catheter recall — Bard Access Systems, Inc.FDA · September 23, 2026
Power-Trialysis Short-Term Straight Dialysis Catheter recall — Bard Access Systems, Inc.FDA · September 23, 2026
BD Needle Kit for Powered Driver 15mm x 15Ga recall — Bard Access Systems, Inc.FDA · August 26, 2026

Other medical device recalls from around the same time

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A M S recall — Windstone Medical Packaging, Inc.FDA · July 8, 2026
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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 6, 2026 at 6:00 PM UTC.

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