Recall Atlas
Drugs & medicalClass II

Medtronic Sofamor Danek USA Inc recalls Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a…

Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch…

Read the official notice →
Date
2026-10-21
Country
United States
Brand
Medtronic Sofamor Danek
Product
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone…
Classification
Class II
Units
US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medtronic Sofamor Danek recalls

  1. 2025-12-03
  2. Drugs & medicalClass II

    Medtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT…

    Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be…

    FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and Puerto Rico. The countries of…Official notice →
  3. 2023-11-01
  4. Drugs & medicalClass II

    Medtronic Sofamor Danek USA Inc recalls Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

    Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have…

    FDA · DeviceMedtronic Sofamor Danek USA IncUS, Colombia, S. Korea, New Zealand, India, TaiwanOfficial notice →
  5. 2023-09-20
  6. Drugs & medicalClass II

    Medtronic Sofamor Danek USA Inc recalls Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

    The incorrect product labeling was applied to the product indicating the wrong size of product.

    FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA,…Official notice →
  7. 2023-08-16
  8. Drugs & medicalClass II

    Medtronic Sofamor Danek USA, Inc recalls CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

    Incorrect Laser Marking - Solera Awl Tip Tap

    FDA · DeviceMedtronic Sofamor Danek USA, IncUS Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.Official notice →
  9. 2023-07-19
  10. Drugs & medicalClass II

    Medtronic Sofamor Danek USA Inc recalls Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit

    There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral…

    FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX,…Official notice →
  11. 2023-05-17
  12. Drugs & medicalClass II

    Medtronic Sofamor Danek USA Inc recalls Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal…

    Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.

    FDA · DeviceMedtronic Sofamor Danek USA IncUS: IN, CT, NEOfficial notice →
All 10 Medtronic Sofamor Danek recalls →

Other drugs & medical recalls in the United States

  1. 2026-10-21
  2. Drugs & medicalClass II

    Neuronetics, Inc. recalls NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced…

    Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

    FDA · DeviceNeuronetics, Inc.Worldwide distribution - US Nationwide and the countries of Japan and South…Official notice →
  3. Drugs & medicalClass II

    Cadwell Industries Inc recalls Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description:…

    Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to…

    FDA · DeviceCadwell Industries IncWorldwide - US Nationwide distribution in the state of TN and the countries of…Official notice →
  4. Drugs & medicalClass II

    Becton Dickinson & Co. recalls BD Phoenix Panel NMIC-312. Catalog Number: 449082.

    Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.

    FDA · DeviceBecton Dickinson & Co.US Nationwide distribution.Official notice →
  5. Drugs & medicalClass II

    Jenavalve Technology Inc. recalls JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L

    Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

    FDA · DeviceJenavalve Technology Inc.US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA, MD, MI,…Official notice →
  6. Drugs & medicalClass I

    Instrumentation Laboratory recalls HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)

    Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

    FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL,…Official notice →
See all drugs & medical recalls →