HIGHFDA DEVICE

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

Potential for product to contain foreign matter, confirmed to be inspect fragments.

DavolHealth & Personal CareMedical DevicesCatalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 25, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 25, 2026
Hazard Level
HIGH
Brand
Davol
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Davol
Model numbers
Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 25, 2026

  2. Reported by FDA DEVICE

    April 29, 2026

  3. RecallRadar source check

    May 6, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Potential for product to contain foreign matter, confirmed to be inspect fragments.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Davol, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.. Reason: Potential for product to contain foreign matter, confirmed to be inspect fragments.. Classification: Class II. Quantity: 1,622 units. Distribution: Worldwide distribution - US Nationwide and the countries of China, South Korea.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Brand
Model Numbers
Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
Affected States
ALL
Report Date
April 29, 2026
Recall Status
ACTIVE