Data Foundry

Medical device recalls 2026

Oxoid Agglutinating Sera — Class II medical device recall Z-1923-2026

Ongoing recall by Remel Europe Ltd., reported 2026-04-29, distributed nationwide. Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-rea

Recall numberZ-1923-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRemel Europe Ltd., Dartford, N/A, United Kingdom
Recall initiated2026-03-25
Classified2026-04-22
Reported by FDA2026-04-29
DistributedNationwide (US)
Reason classesmicrobial contamination
Pathogenssalmonella
UPC / GTIN / UDI-DI05056080500270
Lot numbers3709358, 3719592, 3766399, 3766400, 3780497, 6107767, 6150168, 6171393, 6172600, 6172741, 6222350, 6233858, 6233859, 6253410, 6260215, 6266130

Product

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Reason for recall

Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.

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-1923-2026. 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.