The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1095-2016·Announced 2016-03-23

Pro-Dex Recalls Battery Packs for Surgical Screwdriver Due to Particulates

Pro-Dex Inc is recalling 1,995 sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pro-Dex Inc is recalling 1,995 units of the KLS-SD-1000 Single Battery Pack (Model KLS-BP-001). These battery packs are used to power the KLS Martin Max Driver, a battery-powered surgical screwdriver. The recall was initiated because the sterile battery may contain particulates within the sterile package.

The affected lots are 509567 and K055R. The products were distributed in Florida. The agency has classified this as a Class II recall.

Consumers and healthcare facilities should stop using the affected battery packs and contact Pro-Dex Inc for further instructions on how to return or dispose of the product.

The recalled product

Product
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Manufacturer
Pro-Dex Inc
Category
Medical Device — Surgical Instrument Accessories
Hazard
Affected units
1,995

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lots 509567
  • K055R

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Pro-Dex Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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