Sterilmed recalls

Sterilmed has 9 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 26 Nov 2025. 2 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls9since 2014

Last 12 months2reported

Class I111% of total

Ongoing2latest 26 Nov 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 0Oct 2 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 11%Class II 8 89%Class III 0 0%

Why sterilmed is recalled

Product types

By year

2025222%
2018222%
2017111%
2016111%
2015222%
2014111%

Ongoing sterilmed recalls

2 active

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Device	CLASS II	Reprocessed Imaging Catheter Acuson recalled by Sterilmed	Sterilmed	Lead & Heavy Metals	8 states
26 Nov 2025Device	CLASS II	Catheter Acunav Diagnostic Ultrasound Not For Use recalled by Sterilmed	Sterilmed	Lead & Heavy Metals	8 states

All sterilmed recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Device	CLASS II	Reprocessed Imaging Catheter Acuson recalled by Sterilmed	Sterilmed	Lead & Heavy Metals	8 states
26 Nov 2025Device	CLASS II	Catheter Acunav Diagnostic Ultrasound Not For Use recalled by Sterilmed	Sterilmed	Lead & Heavy Metals	8 states
17 Oct 2018Device	CLASS II	Reprocessed Agilis Steerable Introducer: indicated recalled by Sterilmed	Sterilmed	Device Malfunction	Nationwide
3 Jan 2018Device	CLASS I	St. Jude Medical recalled by Sterilmed	Sterilmed	Sterility	Nationwide
12 Jul 2017Device	CLASS II	Electrophysiology catheter cables are designed as electrode recalled	Sterilmed	Sterility	17 states
8 Jun 2016Device	CLASS II	Reprocessed Microline Scissor Tips intended to be used recalled	Sterilmed	Device Malfunction	28 states
16 Dec 2015Device	CLASS II	Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon recalled	Sterilmed	Sterility	Nationwide
7 Oct 2015Device	CLASS II	Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose recalled	Sterilmed	Labeling Errors	Nationwide
15 Oct 2014Device	CLASS II	Biosense Webster's Reprocessed Soundstar¿ eco Diagnostic recalled	Sterilmed	Sterility	CA, WA

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.