Drugs & medicalClass II

Davol, Inc. recalls 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.

Read the official notice →
Date
2026-04-29
Country
United States
Brand
Davol
Product
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Classification
Class II
Units
Worldwide distribution - US Nationwide and the countries of China, South Korea.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Davol recalls

  1. 2023-08-02
  2. US
    Drugs & medicalClass II

    Davol, Inc. recalls Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning…

    Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration,…

    FDA · DeviceDavol, Inc.Worldwide distribution - US Nationwide and the countries of Belgium, Czech…Official notice →
  3. 2022-08-03
  4. US
    Drugs & medicalClass II

    Davol, Inc. recalls X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

    The device may potentially cause a fire, leading to a safety risk.

    FDA · DeviceDavol, Inc.Worldwide distribution - US Nationwide and the countries of Canada and Chile.Official notice →
  5. 2022-07-06
  6. US
    Drugs & medicalClass II

    Davol, Inc. recalls HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing,…

    The product is not able to provide irrigation.

    FDA · DeviceDavol, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →
All 4 Davol recalls →

Other drugs & medical recalls in the United States

  1. 2026-04-29
  2. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

    XXX

    FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice →
  3. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice →
  4. US
    Drugs & medicalClass II

    XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft…

    Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

    FDA · DeviceXTANT Medical Holdings, IncUS Nationwide distribution in the states and territories of CA, CT, DC, KS,…Official notice →
  5. US
    Drugs & medicalClass II

    Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: "…

    Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results…

    FDA · DeviceMagellan Diagnostics, Inc.Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan,…Official notice →
  6. US
    Drugs & medicalClass II

    Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK…

    Unapproved design changes to the products outside of the 510(k) clearance.

    FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the countries of Canada, Panama,…Official notice →
  7. US
    Drugs & medicalClass II

    Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145…

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

    FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice →
See all drugs & medical recalls →