MEDELA AG
4 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (4)
Devices registered here (1)
- Pump, Portable, Aspiration (Manual Or Powered)Product code BTA (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4780
Recalls & enforcement
- Class IIOngoing2026-06-05May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
- Class IITerminated2019-12-02Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
- Class IIITerminated2018-12-05The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
- Class IITerminated2018-02-07Device may display a battery missing error.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “MEDELA AG (FEI 3002807523) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807523-medela-ag/
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