HomeMedical Device recalls
Medium severity

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateDecember 02, 2025
ReportedDecember 31, 2025
Recalling firmMicrobiologics Inc
Country / regionUnited States MN

Hazard

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Affected products

Related recalls

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS- · May 20, 2026QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. · May 20, 2026Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: · May 20, 2026Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 · May 20, 2026BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER · May 20, 2026