Data Foundry

Medical device recalls 2019

Elasto-Gel Absorbent Wound Dressing — Class II medical device recall Z-0687-2020

Terminated recall by Southwest Technologies Inc, reported 2019-12-25, distributed in CA, GA, IL, KS, NY, OH, TN, TX…. Elasto-Gel Wound Dressing may be contaminated with mold.

Recall numberZ-0687-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSouthwest Technologies Inc, Kansas City, MO, United States
Recall initiated2019-11-18
Classified2019-12-13
Reported by FDA2019-12-25
Terminated2024-08-23
DistributedCA, GA, IL, KS, NY, OH, TN, TX, VA
Reason classesmicrobial contamination
Pathogensmold
Lot numbers1917802
Model numbersDR8000

Product

Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

Reason for recall

Elasto-Gel Wound Dressing may be contaminated with mold.

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-0687-2020. 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.