Data Foundry

Medical device recalls 2020

Invia Foam Dressing Kit with FitPad — Class II medical device recall Z-0773-2020

Terminated recall by Medela Inc, reported 2020-01-08, distributed in AL, AZ, CA, CO, FL, GA, IL, MN…. Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.

Recall numberZ-0773-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMedela Inc, McHenry, IL, United States
Recall initiated2019-12-02
Classified2020-01-02
Reported by FDA2020-01-08
Terminated2020-11-02
DistributedAL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
Quantity331
Reason classessterility
Lot numbers17110012731, 17110022736, 17120012746, 18010012767, 18070012913, 18090012960, 18110013046
Expiration dates2019-11-17, 2019-11-22, 2019-12-08, 2020-09-28

Product

Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).

Reason for recall

Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.

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-0773-2020. 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.