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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

MAHURKAR Acute High Pressure Catheter Trays Recalled for Packaging Seal Issue

Agency Publication Date: November 4, 2025
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Summary

Mozarc Medical US LLC is recalling 3,258 units of MAHURKAR™ Acute High Pressure Triple Lumen Catheter Trays. The recall is due to a potential issue with the seal integrity of the header bag packaging, which may compromise the sterility of the medical device. Consumers should stop using the affected products and contact the manufacturer or their distributor for instructions.

Risk

A compromised package seal can allow the catheter and its components to become non-sterile before use. This poses a significant risk of infection or other serious complications to patients during surgical or medical procedures.

What You Should Do

  1. This recall affects various MAHURKAR™ Acute High Pressure Triple Lumen Catheter Trays, including curved and straight extension models with internal components.
  2. Identify if you have affected products by checking the REF (model) number and lot number on the packaging. Affected REF numbers include 8888101001HP, 8888101002HP, 8888101003HP, 8888102003HP, 8888102004HP, and 8888104004HP. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Mozarc Medical US LLC or your distributor to arrange for the return, replacement, or correction of the affected catheter trays.
  5. Call the FDA at 1-888-463-6332 for additional questions regarding this medical device recall.

Your Remedy Options

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

Affected Products

Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components (12 Fr/Ch (4.0 mm) x 13 cm)
Variants: Curved Extensions, 12 Fr/Ch (4.0 mm) x 13 cm
Model / REF:
8888101001HP
Lot Numbers:
2430500021
UDI:
10884521127890
20884521127897

UDI-DI includes individual unit and carton.

Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components (12 Fr/Ch (4.0 mm) x 16 cm)
Variants: Curved Extensions, 12 Fr/Ch (4.0 mm) x 16 cm
Model / REF:
8888101002HP
Lot Numbers:
2430500017
UDI:
10884521127968
20884521127965

UDI-DI includes individual unit and carton.

Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components (12 Fr/Ch (4.0 mm) x 20 cm)
Variants: Curved Extensions, 12 Fr/Ch (4.0 mm) x 20 cm
Model / REF:
8888101003HP
Lot Numbers:
2424500194
2430500018
UDI:
10884521127975
20884521127972

UDI-DI includes individual unit and carton.

Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components (12 Fr/Ch (4.0 mm) x 20 cm)
Variants: Straight Extensions, 12 Fr/Ch (4.0 mm) x 20 cm
Model / REF:
8888102003HP
Lot Numbers:
2418000195
UDI:
10884521127999
20884521127996

UDI-DI includes individual unit and carton.

Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components (12 Fr/Ch (4.0 mm) x 24 cm)
Variants: Straight Extensions, 12 Fr/Ch (4.0 mm) x 24 cm
Model / REF:
8888102004HP
Lot Numbers:
2424500197
UDI:
10884521128002
20884521128009

UDI-DI includes individual unit and carton.

Product: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components (12 Fr/Ch (4.0 mm) x 24 cm)
Variants: Straight Extensions, Safety Components, 12 Fr/Ch (4.0 mm) x 24 cm
Model / REF:
8888104004HP
Lot Numbers:
2427800166
UDI:
10884521832817
20884521128061

UDI-DI includes individual unit and carton.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97848
Status: Active
Manufacturer: Mozarc Medical US LLC
Sold By: Hospital supply distributors; Medical device wholesalers
Manufactured In: United States
Units Affected: 6 products (3,258 units)
Distributed To: Nationwide

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 · 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.