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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Pro-Dex Inc: Surgical Battery Packs Recalled for Potential Tyvek Shaving Contamination

Agency Publication Date: October 31, 2024
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Summary

Pro-Dex Inc. is recalling approximately 2,000 KLS Martin Battery Packs used to power surgical screwdrivers. The recall was initiated because the sterile packaging may contain Tyvek shavings inside, which could compromise the sterility of the surgical environment. These batteries were distributed exclusively to Florida and are used in conjunction with the MaxDriver 2.0 surgical driver system.

Risk

The presence of Tyvek shavings inside a supposedly sterile package can introduce foreign material into a surgical site or sterile field, increasing the risk of infection or inflammatory response during medical procedures.

What You Should Do

  1. Identify your product by checking for KLS Martin Battery Pack REF: KLS BP2 001 (single) or KLS BP2 040 (bulk case of 40).
  2. Verify the Lot and UDI-DI information on the packaging: Look for Lot/UDI codes 00856482008122, 10856482008129, or 00856482008115.
  3. Immediately stop using any battery packs from the affected lots and quarantine them to prevent further use in surgical procedures.
  4. Contact your healthcare provider or Pro-Dex Inc. at 2361 McGaw Ave, Irvine, CA, 92614-5831 for specific instructions on how to return the affected units and obtain replacements.
  5. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: KLS Martin Battery Pack
Model / REF:
KLS BP2 001
KLS-SD-2000
Lot Numbers:
00856482008122
00856482008115
K0UB9
Product: KLS Martin Battery Pack (bulk case of 40)
Model / REF:
KLS BP2 040
Lot Numbers:
10856482008129

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95510
Status: Active
Manufacturer: Pro-Dex Inc
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 2000
Distributed To: Florida

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.