FDA DevicesClass II
4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOF...
Published: July 8, 2026Recall ID: Z-2668-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Product Description & Identification
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.).
Affected Products
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.).
Additional Source Details
| Field | Value |
|---|---|
| City | Salt Lake City |
| State | UT |
| Event id | 99096 |
| Address 1 | 605 N 5600 W |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 84116-3738 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 11,990 |
| Reason for recall | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260521 |
| Initial firm notification | Letter |
| Center classification date | 20260702 |
Overview
- Recalling FirmBard Access Systems, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.