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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

Medline Surgical Convenience Kits Recalled for Packaging Seal Gaps

Agency Publication Date: November 8, 2024
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Summary

Medline Industries has voluntarily recalled 116 Carrollton Hip FX and Arthroscopy surgical convenience kits due to a packaging error. An incomplete seal formed on the packaging, creating a gap that could compromise the sterile barrier. These kits are used in surgical procedures and were distributed in Tennessee. No incidents or injuries have been reported to date.

Risk

A gap in the packaging seal can allow contaminants into the surgical kit, potentially leading to infections or other medical complications during surgery.

What You Should Do

  1. This recall affects Medline Carrollton Hip FX (SKU SYNJ910003A) and Arthroscopy (SKU SYNJ910004C) surgical convenience kits used for medical procedures.
  2. Check your inventory for Carrollton Hip FX kits with lot number 24EBP466 (UDI-DI 10889942848447) and Arthroscopy kits with lot numbers 24GBI464 or 24HBO800 (UDI-DI 10195327246747).
  3. Stop using the recalled products. Contact Medline Industries or your distributor to arrange for a return, replacement, or correction of the kits.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CARROLLTON HIP FX Convenience kit
Model / REF:
SYNJ910003A
Lot Numbers:
24EBP466
UDI:
10889942848447

Recall number Z-0349-2025; Quantity 36 units.

Product: ARTHROSCOPY Convenience kit
Model / REF:
SYNJ910004C
Lot Numbers:
24GBI464
24HBO800
UDI:
10195327246747

Recall number Z-0350-2025; Quantity 80 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95563
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries, LP
Manufactured In: United States
Units Affected: 2 products (36 units; 80 units)
Distributed To: Tennessee

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.