Z-2098-2023Class II

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS...

Name: Z-2098-2023 KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS...
Creator: Pro-Dex Inc
Published: 2023-02-15
License: https://open.fda.gov/license/

Pro-Dex Inc / initiated 2023-02-15 / Open, Classified / root cause: labeling and UDI

FDA source

Pro-Dex Inc began a recall of KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver on 2023-02-15. FDA classified it as Class II and gives the reason as "Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2098-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-15
Posted: 2023-07-05
Recalling firm: Pro-Dex Inc
Product: KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Product code: GEY Motor, Surgical Instrument, Ac-Powered
Reason for recall: Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 2/15/23, a recall notice was sent to a customer asking them to cease distribution and return affected product to the recalling firm. Questions can be directed to 949-769-3200.
Quantity in commerce: 2000
Distribution: US: FL
Product codes and lots: REF: KLS-BP-001/KLS-BP-040, UDI-DI: 00862377000140, Lot: K0M6U, Expiration: 8/31/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2098-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2098-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-05

Product code GEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)