Data Foundry

Medical device recalls 2026

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563… — Class II medical device recall Z-2668-2026

Ongoing recall by Bard Access Systems, Inc., reported 2026-07-08, distributed nationwide. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocain

Recall numberZ-2668-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBard Access Systems, Inc., Salt Lake City, UT, United States
Recall initiated2026-05-21
Classified2026-07-02
Reported by FDA2026-07-08
DistributedNationwide (US)
Countries outside the USBE
Quantity11,990
Lot numbers4382A, REJZ0942, REJZ0943, REKY3390, REKY3393

Product

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.).

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2668-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.