CLASS II Device recall · Reported 26 Nov 2014 · FDA Enforcement Report

Bag 9732315 Mouse Sterile recalled by Medtronic Navigation

Medtronic Navigation is recalling Bag 9732315 Mouse Sterile, distributed nationwide in the US. The recall was initiated on 24 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No.: 5246110712 5316560113

Quantity recalled26,674 total

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-1578-2014
FDA event ID: 68145
Recalling firm: Medtronic Navigation, Louisville, CO
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2014
FDA classified: 20 Nov 2014
Reported: 26 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

24 Apr 2014	Recall initiated by company
20 Nov 2014	Classified by FDA	+210 days
26 Nov 2014	Published in enforcement report	+6 days

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

Reason for recall

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BAG 9732315 MOUSE STERILE 15 PK

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Bag 9732315 Mouse Sterile recalled?

Yes. Medtronic Navigation recalled Bag 9732315 Mouse Sterile on 24 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1578-2014.

Why was it recalled?

Which lots are affected?

Lot No.: 5246110712 5316560113

Where was it sold?

Nationwide Distribution

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 Medtronic Navigation

All 92

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Sterility	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 3.0 and 3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	Stealth S8 Clinical recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled	Medtronic Navigation	Sterility	Nationwide

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