KLS Martin Battery Pack (Pro-Dex) – Tyvek Shavings (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Pro-Dex Inc
Lot Codes / Batch Numbers
Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Products Sold
Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Pro-Dex Inc is recalling KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction wi due to The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Recommended Action
Per FDA guidance
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 Recall@Pro-Dex.com or FAX 949.769.3281. Questions or concerns can be directed to the firm at 949-769-3200 or Recall@Pro-Dex.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL
Page updated: Jan 10, 2026