CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report

Battery Pack Kls-sd recalled by Pro-Dex

Pro-Dex is recalling Battery Pack Kls-sd, distributed in Florida. The recall was initiated on 23 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 509567, K055R

Quantity recalled1995 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-1095-2016
FDA event ID: 73034
Recalling firm: Pro-Dex, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 23 Dec 2015
FDA classified: 11 Mar 2016
Reported: 23 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Surgical Instruments

Timeline

23 Dec 2015	Recall initiated by company
11 Mar 2016	Classified by FDA	+79 days
23 Mar 2016	Published in enforcement report	+12 days

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

Reason for recall

The sterile battery may contain particulates within the sterile package.

Product as listed by the FDA

Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

Where it was distributed

Distributed in FL.

Florida

Questions about this recall

Is Battery Pack Kls-sd recalled?

Yes. Pro-Dex recalled Battery Pack Kls-sd on 23 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-1095-2016.

Why was it recalled?

The sterile battery may contain particulates within the sterile package.

Which lots are affected?

Lots 509567, K055R

Where was it sold?

Distributed in FL.

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 Pro-Dex

All 6

Reported	Class	Recall	Company	Reason	Where
6 Nov 2024Device	CLASS II	KLS Martin Battery Pack recalled by Pro-Dex	Pro-Dex	Sterility	FL
12 Jul 2023Device	CLASS II	KLS Martin Battery Pack recalled by Pro-Dex	Pro-Dex	Sterility	FL
26 Apr 2023Device	CLASS II	Kls martin Group Kls E-coupling Adapter recalled by Pro-Dex	Pro-Dex	Other	Nationwide
28 Aug 2019Device	CLASS II	Surgical Driver Battery Pack Pdbp-001 Series Pro-dex recalled	Pro-Dex	Particulate Matter	Nationwide
23 Mar 2016Device	CLASS II	Battery Pack Kls-sd recalled by Pro-Dex	Pro-Dex	Particulate Matter	FL

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