Erbe USA Recalls Flexible Cryoprobes Due to Injury or Death Risk
Summary
Erbe USA is recalling flexible cryoprobes due to a risk of serious injury or death from device rupture during activation. The FDA has identified this as the most serious type of recall. Customers are instructed to discontinue use, remove, and quarantine affected devices.
What changed
Erbe USA has issued a recall for specific flexible cryoprobes due to a manufacturing defect where insufficient adhesive can cause the device to rupture during activation. This rupture can lead to loud noises causing hearing damage, as well as physical injuries and burns. The FDA has classified this as its most serious recall category, with five serious injuries reported to date. The recall affects specific part numbers and lot numbers, with a full list available.
Healthcare providers using these devices must immediately discontinue use, identify, remove, and quarantine all affected cryoprobes. Customers are required to notify any locations to which the product may have been transferred or further distributed. Questions or adverse reactions should be directed to Erbe USA's customer service.
What to do next
- Discontinue use of affected Erbe Flexible Cryoprobes.
- Identify, remove, and quarantine all affected devices.
- Notify any downstream locations or personnel who received affected products.
Source document (simplified)
The affected products have been updated to remove a part number with no affected lots. The recommendations for what to do with the devices below have not changed. This recall **involves removing certain devices from where they are used or sold.* The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.*
Affected Product
The FDA is aware that Erbe USA has issued a letter to affected customers recommending certain Erbe Flexible Cryprobes be removed from where they are used or sold. Affected devices:
| Part Number | Part Description | Unique Device Identifier |
| --- | --- | --- |
| 20402-401 | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) | Each: 04050147021778
Pack: 04050147021785 |
| 20402-410 | Flexible Cryoprobe (OD 1.7mm, L1.15mm) | Each: 04050147021815
Pack: 04050147021822 |
| 20402-411 | Flexible Cryoprobe (OD 2.4mm, L1.15mm) | Each: 04050147021839
Pack: 04050147021846 |
Full list of affected lots: Erbe Cryoprobe Affected Lots
What to Do
Discontinue use of affected products. Identify, remove, and quarantine affected devices.
On February 12, Erbe USA sent all affected customers a letter requesting their customers take the following actions:
- Discontinue use of products with the affected lot numbers.
- Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers.
- Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification.
- If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification.
- If you have further distributed this product, identify your locations, and forward this notification to them.
Reason for Recall
Erbe USA has reported instances of the affected Cryoprobes rupturing or bursting during activation. The rupture is caused by insufficient adhesive being applied during production, leading to excessive input pressure.
The rupture causes a loud sound which could cause tinnitus, temporary hearing loss, or persistent hearing loss to patients, healthcare professionals, or any person near the device when activated. The rupture of the device may also lead to injuries and burns.
As of February 24, Erbe USA has reported five serious injuries, and no deaths associated with this issue.
Device Use
Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Erbe USA at 770-955-4400.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Timeline of Communication Updates
| Date | Actions |
| --- | --- |
| 03/25/2026 | The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall and remove a part number with no affected lots. |
| 03/10/2026 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |
- ## Content current as of:
03/25/2026
Regulated Product(s)
- Medical Devices
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