Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Establishment Labs medical devices: approvals, recalls and adverse events

Stock: ESTA. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: -

PMA approvals

- supplements

Recalled products

- class I

Adverse event reports

2,683

- deaths reported

How many recalls does Establishment Labs have?

Establishment Labs has - recalled medical device products in - recall actions in the records, - of them class I (the most serious kind).

How many medical devices has Establishment Labs had cleared or approved?

- 510(k) clearances, - De Novo grants and - original PMA approvals for high-risk devices, plus - PMA supplements (changes to approved devices).

How many adverse event reports name Establishment Labs devices?

2,683 reports in total: - deaths, 2,526 injuries and 157 malfunctions were reported. 1,415 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement

Recalls and adverse event reports by year

Recalled products, class I, and reports received

Year	Recalls	Class I	Reports	Deaths
2026	0

Newest clearances and approvals

Newest recalls

Devices with the most adverse event reports

By product code, all years

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (FTR, class 3)2,604
Tissue Expander And Accessories (LCJ, class U)72
Mammary Sizer (MRD, class U)3
Unit, Isolation, Surgical (FRT, class 2)3
Enteroscope And Accessories (FDA, class 2)1

All device makers and procedures · ESTA stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to ESTA with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.