Marietta, GA, United States
Erbe USA Inc recalls
2 recalls recorded since 2018, most recently on 26 June 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 26 June 2026
- Reason
- A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
- Distribution
- US Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michig
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2938-2026
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Ongoing Class I Medical devices
- Recall started
- 12 February 2026
- Reason
- Probes may rupture/burst during activation
- Distribution
- US Nationwide distribution, including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1566-2026, Z-1568-2026, Z-1567-2026
- Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
- Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
- Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.