FDA Device recall Z-0965-2017
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disi…
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disi… by Advanced Sterilization Products, citing advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0965-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-27 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.
Reason
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Identifiers
| code_info | UDI 10705037030958 Serial No. 5041150187 UDI 10705037030958 Serial No. 5041150188 UDI 10705037030…UDI 10705037030958 Serial No. 5041150187 UDI 10705037030958 Serial No. 5041150188 UDI 10705037030958 Serial No. 5041150189 UDI 10705037030958 Serial No. 5041150192 UDI 10705037030958 Serial No. 5041150191 UDI 10705037030958 Serial No. 5041150190 UDI 10705037030958 Serial No. 5041150193 UDI 10705037030958 Serial No. 5041150205 UDI 10705037030958 Serial No. 5041150212 UDI 10705037030958 Serial No. 5041150207 UDI 10705037030958 Serial No. 5041150213 UDI 10705037030958 Serial No. 5041150206 UDI 10705037030958 Serial No. 5041150204 UDI 10705037030958 Serial No. 5041150210 UDI 10705037030958 Serial No. 5041150198 UDI 10705037030958 Serial No. 5041150228 UDI 10705037030958 Serial No. 5041150230 UDI 10705037030958 Serial No. 5041150229 UDI 10705037030958 Serial No. 5041150227 UDI 10705037 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Advanced Sterilization Products
- STERRAD NX Sterilization System, Product Code: 10033, 10033-002
FDA Device · Class II · 2017-02-22 · Advanced Sterilization Products - CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices
FDA Device · Class II · 2015-09-23 · Advanced Sterilization Products - CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
FDA Device · Class II · 2015-09-02 · Advanced Sterilization Products - Wall Chart for STERRAD 100NX System, P/N 10104
FDA Device · Class II · 2015-08-19 · Advanced Sterilization Products - EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004
FDA Device · Class II · 2015-06-17 · Advanced Sterilization Products
All Advanced Sterilization Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0965-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.