Z-0280-2025Class II

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the...

Name: Z-0280-2025 KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the...
Creator: Pro-Dex Inc
Published: 2024-09-23
License: https://open.fda.gov/license/

Pro-Dex Inc / initiated 2024-09-23 / Open, Classified / root cause: design

FDA source

Pro-Dex Inc began a recall of KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF... on 2024-09-23. FDA classified it as Class II and gives the reason as "The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0280-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-23
Posted: 2024-10-31
Recalling firm: Pro-Dex Inc
Product: KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
Product code: MOQ Battery, Replacement, Rechargeable
Reason for recall: The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 9/23/24, an "URGENT" recall notice was emailed to the customer informing of the product, issue, risk and actions to be taken. Customers were instructed to do the following: 1) Please immediately cease distribution and use of these lots. Inventory and distribution records should be evaluated to ensure that affected product is removed from any potential point of use. 2) Product should be returned to the recalling firm. 3) The Recall Acknowledgement and Return Form should be completed and returned via email to [email protected] or FAX 949.769.3281. Questions or concerns can be directed to the firm at 949-769-3200 or [email protected]
Quantity in commerce: 2000
Distribution: US distribution to FL only.
Product codes and lots: Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0280-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0280-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-31

Product code MOQ

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)