CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
KLS Martin Battery Pack recalled by Pro-Dex
Pro-Dex is recalling KLS Martin Battery Pack, distributed in Florida. The recall was initiated on 23 Sep 2024 and the FDA has classified it as Class II.
Check your package
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-0280-2025
- FDA event ID
- 95510
- Recalling firm
- Pro-Dex, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Sep 2024
- FDA classified
- 31 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 23 Sep 2024 | Recall initiated by company | |
| 31 Oct 2024 | Classified by FDA | +38 days |
| 6 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US distribution to FL only.
Questions about this recall
Why was it recalled?
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Which lots are affected?
Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Where was it sold?
US distribution to FL only.
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.
More recalls from Pro-Dex
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | KLS Martin Battery Pack recalled by Pro-Dex | Pro-Dex | Sterility | FL |
| Device | CLASS II | Kls martin Group Kls E-coupling Adapter recalled by Pro-Dex | Pro-Dex | Other | Nationwide |
| Device | CLASS II | Surgical Driver Battery Pack Pdbp-001 Series Pro-dex recalled | Pro-Dex | Particulate Matter | Nationwide |
| Device | CLASS II | Battery Pack Kls-sd recalled by Pro-Dex | Pro-Dex | Particulate Matter | FL |
| Device | CLASS II | Battery Pack Kls-sd recalled by Pro-Dex | Pro-Dex | Particulate Matter | FL |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |