Sophysa recalls

Sophysa has 3 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 14 Jan 2026. 3 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is packaging defects.

Total recalls3since 2024

Last 12 months1reported

Class I00% of total

Ongoing3latest 14 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 1 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why sophysa is recalled

Packaging Defects267%
Other Reasons133%

Product types

Spinal Implants267%
Patient Monitors133%

By year

2026133%
2024267%

Ongoing sophysa recalls

3 active

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Device	CLASS II	The Pressio 2 ICP Monitoring System recalled by Sophy	Sophysa	Other	Nationwide
22 May 2024Device	CLASS II	Pressio¿ Ventricular Intracranial Pressure Monitoring Kit recalled	Sophysa	Packaging Defects	Nationwide
22 May 2024Device	CLASS II	Pressio¿ Ventricular Intracranial Pressure Monitoring Kit recalled	Sophysa	Packaging Defects	Nationwide

All sophysa recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Device	CLASS II	The Pressio 2 ICP Monitoring System recalled by Sophy	Sophysa	Other	Nationwide
22 May 2024Device	CLASS II	Pressio¿ Ventricular Intracranial Pressure Monitoring Kit recalled	Sophysa	Packaging Defects	Nationwide
22 May 2024Device	CLASS II	Pressio¿ Ventricular Intracranial Pressure Monitoring Kit recalled	Sophysa	Packaging Defects	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.