FDA Device recall 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 Martin MaxDriver
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II 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 by Pro Dex, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2098-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-15 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Pro Dex |
| Distribution | FL |
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
Reason
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.
Identifiers
| code_info | REF: KLS-BP-001/KLS-BP-040, UDI-DI: 00862377000140, Lot: K0M6U, Expiration: 8/31/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2098-2023%22
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