Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product… — Class II medical device recall Z-0295-2019
Ongoing recall by Arthrex, Inc., reported 2018-11-07, distributed nationwide. The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around th
| Recall number | Z-0295-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arthrex, Inc., Naples, FL, United States |
| Recall initiated | 2018-08-27 |
| Classified | 2018-10-30 |
| Reported by FDA | 2018-11-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HR, IT, KW, LT, NL, NO, PL, RU, SK |
| Quantity | 335 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00888867223349 |
| Lot numbers | GB3854432, GB3854434, GB3854435, GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191 |
Product
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
Reason for recall
The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0295-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.