CLASS II Device recall · Reported 8 Jan 2020 · FDA Enforcement Report
Invia Foam Dressing Kit with FitPad - X-Large recalled by Medela
Medela is recalling Invia Foam Dressing Kit with FitPad - X-Large, distributed in 16 states. The recall was initiated on 2 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0773-2020
- FDA event ID
- 84368
- Recalling firm
- Medela, McHenry, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 2 Jan 2020
- Reported
- 8 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 2 Jan 2020 | Classified by FDA | +31 days |
| 8 Jan 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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).
Where it was distributed
AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisMinnesotaMissouriNorth CarolinaNew YorkPennsylvaniaSouth CarolinaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Which lots are affected?
Lots: 17110012731 / Exp 17-Nov-19, 17110022736 / Exp 22-Nov-19, 17120012746 / Exp 8-Dec-19, 18010012767 / 4-Jan-20, 18070012913 / 31-Jul-20, 18090012960 / Exp 28-Sep-20, 18110013046 / 5-Nov-20.
Where was it sold?
AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medela
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ENFit ExSet Strl 60 PV EN recalled by Medela | Medela | Device Malfunction | 18 states |
| Device | CLASS III | Breast Milk Transfer Lid for use with Oral Syringe Connectors recalled | Medela | Sterility | Nationwide |
| Device | CLASS II | Invia Motion Negative Pressure Wound Therapy System recalled by Medela | Medela | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |