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Lower risk Medical device recall · FDA · Published August 27, 2018

Arthrex Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System May Allow Fluid

Arthrex recalls Li-ion battery housings for AR-400 DrillSaw Sports 400 systems due to potential fluid ingress. Affected units have specific batch numbers and material codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0295-2019Medical deviceArthrex ›
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Contact the company

Recalling firmArthrex, Inc.1370 Creekside Blvd · Naples, FL 34108-1945
✎ GovInfoNow plain-language explainer

Arthrex is recalling the Li-ion battery housing for their AR-400 DrillSaw Sports 400 system because it may not seal properly, allowing fluids to enter. This could lead to damage or malfunction of the device. Read more at govinfonow.com/recall/69965-arthrex-li-ion-battery-housing-for-ar-400-drillsaw-sports.

Source Summary by GovInfoNow · govinfonow.com/recall/69965-arthrex-li-ion-battery-housing-for-ar-400-drillsaw-sports · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0295-2019

Cite this page

“Arthrex Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System May Allow Fluid.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69965-arthrex-li-ion-battery-housing-for-ar-400-drillsaw-sports. Based on FDA recall #Z-0295-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0295-2019%22&limit=1).

The Food and Drug Administration announced on August 27, 2018, that Arthrex, Inc. is recalling Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System because it may not provide a complete seal around the battery, allowing for potential fluid ingress.

How to tell if you have it

  • Brand: Arthrex
  • Product: Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System
  • UDI Number: 0888867223349
  • Material Number: AR-400UBH
  • Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435
  • Units affected: 335 devices

The hazard

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.

Context

GovInfoNow's records show Arthrex has 12 other recalls on record since October 3, 2017. Other recent recalls include an Arthrex Small Joint OATS Set recalled on November 2, 2022, due to wrong reamer size packaging and an Arthrex K-Wire 1.35mm x 170mm recalled on March 25, 2022, for incorrect size risk. A Suture Anchor was also recalled by the brand on June 14, 2021, because it was not sterilized due to a packaging seal issue.

How to tell if you have this one

Check for the batch numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435. The material number is AR-400UBH.

  • Brand
    Arthrex
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Battery Housing Batch

    Identify the batch number on the battery housing to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 19 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - Nationwide Distribution in the states of AL, CA, CO, FL, ID, IL, MA, MD, MI, MO, NC, NE, NY, PA, SC, TN, TX, UT, WI. and the countries of Austria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Colorado, Florida, Idaho, Illinois, Maryland, Massachusetts, Michigan, Missouri, Nebraska, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 27, 201812. FDA classified it Class II: Oct 30, 201823. Published in FDA’s Enforcement Report: Nov 7, 201832018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0295-2019 (August 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0295-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA