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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

Hollister, McKesson, and Medline Dressings Recalled for Sterility Loss

Agency Publication Date: December 4, 2024
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Summary

This recall affects approximately 13,700 boxes of calcium alginate wound dressings sold under the Hollister, McKesson, and Medline brands. Advanced Medical Solutions Ltd. initiated the recall because of defects in the primary packaging pouches that can compromise the sterile barrier. Using a non-sterile dressing on a wound could lead to serious infections. No injuries or incidents have been reported to date.

Risk

A defect in the packaging pouch allows the product to lose its sterility. Using a non-sterile wound dressing on chronic or acute wounds—such as pressure ulcers, leg ulcers, or surgical sites—poses a significant risk of introducing bacteria or other contaminants directly into the wound, which can lead to infection.

What You Should Do

  1. This recall involves Hollister CalciCare, McKesson Calcium Alginate, and Medline MaxOrb Extra Alginate wound dressings used to treat moderate to heavily exuding wounds and surgical sites.
  2. Identify your product by checking the brand name and model/reference numbers on the box: Hollister (REF 529937R), McKesson (MFR# 3562), or Medline (REF MSC7044EP or MSC7048EP). See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) 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: Hollister CalciCare Calcium Alginate Dressing
Model / REF:
529937R
Lot Numbers:
W00070134
UDI:
0060075029530

Indicated for pressure ulcers, leg ulcers, cavity wounds, lacerations, and post-operative surgical wounds.

Product: McKesson Calcium Alginate Dressing
Model / REF:
3562
Lot Numbers:
W00070426
UDI:
10612479193861

Indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.

Product: Medline MaxOrb Extra Alginate Wound Dressing 4x4 Square
Variants: 4x4 Square
Model / REF:
MSC7044EP
Lot Numbers:
W00070789
UDI:
10080196296842

Indicated for moderate to heavily exuding chronic and acute wounds.

Product: Medline MaxOrb Extra Alginate Wound Dressing 4x8 Rectangle
Variants: 4x8 Rectangle
Model / REF:
MSC7048EP
Lot Numbers:
W00070988
UDI:
10080196296828

Indicated for moderate to heavily exuding chronic and acute wounds.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95613
Status: Active
Manufacturer: Advanced Medical Solutions Ltd.
Sold By: Hollister; McKesson; Medline
Manufactured In: United Kingdom
Units Affected: 3 products (3900 boxes; 8000 boxes; 1,800 boxes)
Distributed To: Illinois, Texas, Virginia

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.