Erbe USA Inc
FDA Regulatory Profile
Erbe USA Inc appears in FDA public data with 3 recalls — including 3 Class I (most serious) —, 39 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1566-2026, Class I) was initiated on February 12, 2026. Its most recent 510(k) clearance was granted on August 11, 2022.
Summary
- Total Recalls
- 3 (3 Class I)
- 510(k) Clearances
- 39
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1566-2026 | Class I | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. F | February 12, 2026 |
| Z-1567-2026 | Class I | Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use | February 12, 2026 |
| Z-1568-2026 | Class I | Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use | February 12, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221177 | Erbe's Tubing/Cap Sets | August 11, 2022 |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | June 27, 2019 |
| K190469 | ERBEFLO 2 Disposable Tubing System | May 23, 2019 |
| K182444 | ERBEFLO Olympus Scope Port Connector | November 6, 2018 |
| K162152 | Erbes CO2 Tubing/Cap Sets | August 31, 2016 |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | October 27, 2015 |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | May 4, 2015 |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector | December 18, 2014 |
| K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP S | December 17, 2013 |
| K133180 | ERBE ESU MODEL VIO DV WITH ACCESSORIES | December 11, 2013 |
| K103696 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES | March 22, 2011 |
| K103235 | ERBEFLO 2 DISPOSABLE TUBING SYSTEM | December 23, 2010 |
| K101108 | ERBE ESU MODEL VIO 100 C WITH ACCESSORIES | July 16, 2010 |
| K083608 | ERBE HYBRID KNIFE | August 26, 2009 |
| K083452 | ERBE MODEL VIO 300 D WITH ACCESSORIES | December 31, 2008 |
| K080715 | ERBE VIO ESU, MODEL VIO 200 S | April 2, 2008 |
| K072404 | ERBE ERBEJET 2 SYSTEM | October 31, 2007 |
| K062712 | ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 | January 26, 2007 |
| K060484 | ERBE VIO ESU, MODEL VIO 300 D | March 16, 2006 |
| K060183 | ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER | February 16, 2006 |