Data Foundry

Medical device recalls 2023

abm Respiratory Care Standart Breating Circuit with Face Mask — Class III medical device recall Z-1160-2023

Ongoing recall by S & MOHR AMERICA, S.A. DE C.V., reported 2023-03-01, distributed nationwide. Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct

Recall numberZ-1160-2023
Product typeMedical device
ClassificationClass III
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmS & MOHR AMERICA, S.A. DE C.V., Estado De Mexico, N/A, Mexico
Recall initiated2023-01-05
Classified2023-02-22
Reported by FDA2023-03-01
DistributedNationwide (US)
Quantity1,320 masks
Reason classeslabeling
Lot numbersSM6001.2207.12, SM6002.2207.12, SM6003.2507.12, SM6004.2607.12
Model numbersBC21087, BC21088, BC21089, BC21273

Product

abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089

Reason for recall

Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

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-1160-2023. 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.