Zap Surgical Systems recalls

Zap Surgical Systems has 2 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 8 Oct 2025. 2 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is lead & heavy metals.

Total recalls2since 2022

Last 12 months1reported

Class I00% of total

Ongoing2latest 8 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why zap surgical systems is recalled

Lead & Heavy Metals150%
Processing Deviation150%

Product types

Other Medical Devices2100%

By year

2025150%
2022150%

Ongoing zap surgical systems recalls

2 active

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025Device	CLASS II	Zap-x Radiosurgery System recalled by Zap Surgical Systems	Zap Surgical Systems	Lead & Heavy Metals	Nationwide
21 Sep 2022Device	CLASS II	Zap-x Radiosurgery System recalled by Zap Surgical Systems	Zap Surgical Systems	Processing Deviation	Nationwide

All zap surgical systems recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
8 Oct 2025Device	CLASS II	Zap-x Radiosurgery System recalled by Zap Surgical Systems	Zap Surgical Systems	Lead & Heavy Metals	Nationwide
21 Sep 2022Device	CLASS II	Zap-x Radiosurgery System recalled by Zap Surgical Systems	Zap Surgical Systems	Processing Deviation	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.