CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report

Kls martin Group Kls E-coupling Adapter recalled by Pro-Dex

Pro-Dex is recalling Kls martin Group Kls E-coupling Adapter, distributed nationwide in the US. The recall was initiated on 14 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV

Quantity recalled199 devices

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-1391-2023
FDA event ID: 91850
Recalling firm: Pro-Dex, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Feb 2023
FDA classified: 14 Apr 2023
Reported: 26 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Feb 2023	Recall initiated by company
14 Apr 2023	Classified by FDA	+59 days
26 Apr 2023	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

Incorrect Unique Device Identifier/GTIN code was used on product.

Product as listed by the FDA

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

Where it was distributed

U.S. Nationwide distribution in the state of FL.

Nationwide Florida

Questions about this recall

Why was it recalled?

Incorrect Unique Device Identifier/GTIN code was used on product.

Which lots are affected?

Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV

Where was it sold?

U.S. Nationwide distribution in the state of 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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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
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
23 Mar 2016Device	CLASS II	Battery Pack Kls-sd recalled by Pro-Dex	Pro-Dex	Particulate Matter	FL

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