Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes

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 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.