Sterilmed, Inc.

FDA recalling firm · 8 enforcement events · 9 product records · 2014–2025 · MN

Sterilmed, Inc. has 8 FDA enforcement events on this register (9 product records) between 2014 and 2025: 8 device; the busiest year was 2015 with 2.

13% of its events are Class I; the most common class is Class II (7). 1 event is listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
8 Oct 2025	Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR…	Device	Class II	2	Ongoing
17 Sep 2018	Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length),…	Device	Class II	1	Terminated
2 Jun 2017	St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various…	Device	Class I	1	Terminated
8 May 2017	Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP…	Device	Class II	1	Terminated
26 Apr 2016	Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.	Device	Class II	1	Terminated
13 Nov 2015	Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.	Device	Class II	1	Terminated
24 Aug 2015	Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.	Device	Class II	1	Terminated
24 Sep 2014	Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.	Device	Class II	1	Terminated

By type and class

Device8

Class II7

Class I1

Class I: 13% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Sterilmed, Inc. by year initiated.

Questions and answers

How many FDA recalls has Sterilmed, Inc. had?

8 enforcement events (9 product records) on this register, 2014–2025: 8 device.

Are any Sterilmed, Inc. recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Sterilmed, Inc. recalls?

7 Class II, 1 Class I. 13% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.