Medela Invia Foam Dressing Kit Recalled for Packaging Defects
Medela Inc is recalling Invia Foam Dressing Kits with FitPad because holes in the sterile packaging may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medela Inc is recalling 331 units of the Invia Foam Dressing Kit with FitPad - X-Large (3 pcs), SKU # 0876224. The recall is due to a defect where the sterile packaging may contain holes, which could compromise the sterility of the medical device.
The affected product consists of a foam pad, a section interface (Invia FitPad), and Transparent Film. The recall covers specific lots with expiration dates ranging from November 2019 to November 2020. Distribution was limited to 16 states, including Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, New York, Pennsylvania, South Carolina, Tennessee, Texas, and Washington.
Consumers who have this product should stop using it and contact Medela Inc for further instructions or a replacement.
The recalled product
- 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).
- Manufacturer
- Medela Inc
- Category
- Medical Device — Wound Care
- Affected units
- 331
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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.
Distribution
Related recalls
Same manufacturer · Medela Inc
See all →- ModerateMedela ENFit ExSet Enteral Extension Set Connector Compatibility Issue
FDA (Devices) · 2026-07-08
- ModerateMedela Breast Milk Transfer Lid Recall for Packaging Sterility Concerns
FDA (Devices) · 2019-07-31
- HighMedela Invia Motion Negative Pressure Wound Therapy System Recalled for Battery Error
FDA (Devices) · 2018-08-01
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighCenturion Medical Recalls LVAD Dressing Kits Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- HighDressing change kits recalled due to packaging defect compromising sterility
FDA (Devices) · 2025-01-29
- HighSterile Surgical Drape Recalled Due to Potential Packaging Breach
FDA (Devices) · 2025-03-26
- CriticalCustomed Recalls Endovascular Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- HighMedline Sterile Probe Covers Recalled for Inadequate Seam Barriers
FDA (Devices) · 2023-07-26
- HighIntervertebral fusion device recalled for packaging non-conformity issue
FDA (Devices) · 2023-08-30