CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report

Reprocessed Agilis Steerable Introducer: indicated recalled by Sterilmed

Sterilmed is recalling Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular, distributed nationwide in the US. The recall was initiated on 17 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912 (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950

Quantity recalled218 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0090-2019
FDA event ID: 80999
Recalling firm: Sterilmed, Plymouth, MN
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2018
FDA classified: 9 Oct 2018
Reported: 17 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

17 Sep 2018	Recall initiated by company
9 Oct 2018	Classified by FDA	+22 days
17 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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), Product Code STJ408324

Where it was distributed

U.S. Nationwide distribution in the states of CA, CO, MN, and WA.

Nationwide California Colorado Minnesota Washington

Questions about this recall

Is Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular recalled?

Yes. Sterilmed recalled Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular on 17 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0090-2019.

Why was it recalled?

Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

Which lots are affected?

All lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912 (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950

Where was it sold?

U.S. Nationwide distribution in the states of CA, CO, MN, and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Sterilmed

All 9

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
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

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide