Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Recall
- Recall Number
- Z-1567-2026
- Event Number
- 98429
- Firm
- Erbe USA Inc
- FEI Number
- 1000140388
- Product Code
- GEH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- February 12, 2026
- Posted
- March 20, 2026
- Address
- 2225 Northwest Pkwy SE, Marietta, GA, 30067-8764
Description
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Probes may rupture/burst during activation
On February 12, 2026, ERBE USA issued a "Urgent: Medical Device Recall (Removal)" via E-Mail. ERBE asked consignees to take the following actions: 1. Discontinue use of the products with the affected lot numbers. 2.Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers 3.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. 4.Please contact Erbe at [email protected] or 678-483-8499, to obtain a Return Material Authorization number 5.Please complete the Response Form and return to Erbe 6.If a response is not received within 4 weeks of this letter, Erbe will provide a second and third reminder in 4-week increments. 7.If you have further distributed this product, identify your locations, and forward this notification to them. 8.Erbe requests you to report any complaints, including any instances of ruptures/bursts, to our Technical Service Department at 770-955-4400. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program.
US Nationwide distribution, including Puerto Rico.
5154 units