Route 92 Medical recalls

Route 92 Medical has 5 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 1 May 2024. 5 are still ongoing. The most frequent reason is sterility.

Total recalls5since 2024

Last 12 months0reported

Class I5100% of total

Ongoing5latest 1 May 2024

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 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 5 100%Class II 0 0%Class III 0 0%

Why route 92 medical is recalled

Sterility5100%

Product types

Other Medical Devices480%
Heart & Vascular Devices120%

By year

20245100%

Ongoing route 92 medical recalls

5 active

Reported	Class	Recall	Company	Reason	Where
1 May 2024Device	CLASS I	070 Reperfusion System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	Full Length 070 Access System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	Full Length 070 Reperfusion System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	Tenzing 7 Delivery Catheter recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	070 Access System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states

All route 92 medical recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
1 May 2024Device	CLASS I	070 Reperfusion System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	Full Length 070 Access System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	Full Length 070 Reperfusion System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	Tenzing 7 Delivery Catheter recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states
1 May 2024Device	CLASS I	070 Access System recalled by Route 92 Medical	Route 92 Medical	Sterility	26 states

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.