EVOTECH Endoscope Cleaner and Reprocessor System 208V… recallZ-0965-2017 · Advanced Sterilization Products · initiated Sep 27, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Sterilization Products or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
FDA root cause category: Nonconforming Material/Component
What the company is doing
ASP has sent out Service Representatives to all impacted customers to inspect the hoses for the EVOTECH Endoscope Cleaner and Reprocessor System and will replace the hose if required. The firm issued a Technical Bulletin dated 8/22/2016. Customers were instructed to complete online training prior to performing the actions described in the bulletin and follow instructions. For orders and questions call 888-783-7723 or email: [email protected].
Recall details
- Recall number
- Z-0965-2017
- Status
- Terminated
- Initiated by the company
- Sep 27, 2016
- Posted by the FDA
- Jan 9, 2017
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 107 units
- Product code
- FEB
- FDA submissions
- K040883, K061889, K082392, K140977, K152189
- Distribution
- US Nationwide Distribution.
Product description
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 (>60C} semi-critical endoscopes.
Code information (models, lots, serial numbers)
Show the full code information (5k characters)
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 10705037030958 Serial No. 5041150226 UDI 10705037030958 Serial No. 5041150209 UDI 10705037030958 Serial No. 5041150231 UDI 10705037030958 Serial No. 5041150197 UDI 10705037030958 Serial No. 5041150236 UDI 10705037030958 Serial No. 5041150211 UDI 10705037030958 Serial No. 5041150235 UDI 10705037030958 Serial No. 5041150233 UDI 10705037030958 Serial No. 5041150234 UDI 10705037030958 Serial No. 5041150232 UDI 10705037030958 Serial No. 5041150196 UDI 10705037030958 Serial No. 5041150195 UDI 10705037030958 Serial No. 5041150199 UDI 10705037030958 Serial No. 5041150194 UDI 10705037030958 Serial No. 5041150202 UDI 10705037030958 Serial No. 5041150245 UDI 10705037030958 Serial No.5041150248 UDI 10705037030958 Serial No. 5041150246 UDI 10705037030958 Serial No. 5041150241 UDI 10705037030958 Serial No. 5041150247 UDI 10705037030958 Serial No. 5041150240 UDI 10705037030958 Serial No. 5041150242 UDI 10705037030958 Serial No. 5041150208 UDI 10705037030958 Serial No. 5041150239 UDI 10705037030958 Serial No. 5041150238 UDI 10705037030958 Serial No. 5041150237 UDI 10705037030958 Serial No. 5041150203 UDI 10705037030958 Serial No. 5041150200 UDI 10705037030958 Serial No. 5041150201 UDI 10705037030958 Serial No. 5041150244 UDI 10705037030958 Serial No. 5041150243 UDI 10705037030958 Serial No. 5041150251 UDI 10705037030958 Serial No. 5041150252 UDI 10705037030958 Serial No. 5041150250 UDI 10705037030958 Serial No. 5041150288 UDI 10705037030958 Serial No. 5041150290 UDI 10705037030958 Serial No. 5041150280 UDI 10705037030958 Serial No. 5041150253 UDI 10705037030958 Serial No. 5041150249 UDI 10705037030958 Serial No. 5041150254 UDI 10705037030958 Serial No. 5041150255 UDI 10705037030958 Serial No. 5041150282 UDI 10705037030958 Serial No. 5041150285 UDI 10705037030958 Serial No. 5041150286 UDI 10705037030958 Serial No. 5041150292 UDI 10705037030958 Serial No. 5041150287 UDI 10705037030958 Serial No. 5041150284 UDI 10705037030958 Serial No. 5041150289 UDI 10705037030958 Serial No. 5041150293 UDI 10705037030958 Serial No. 5041150302 UDI 10705037030958 Serial No. 5041150291 UDI 10705037030958 Serial No. 5041150301 UDI 10705037030958 Serial No. 5041150304 UDI 10705037030958 Serial No. 5041150305 UDI 10705037030958 Serial No. 5041150283 UDI 10705037030958 Serial No. 5041150328 UDI 10705037030958 Serial No. 5041150326 UDI 10705037030958 Serial No. 5041150306 UDI 10705037030958 Serial No. 5041150323 UDI 10705037030958 Serial No. 5041150324 UDI 10705037030958 Serial No. 5041150307 UDI 10705037030958 Serial No. 5041150310 UDI 10705037030958 Serial No. 5041150321 UDI 10705037030958 Serial No. 5041150320 UDI 10705037030958 Serial No. 5041150322 UDI 10705037030958 Serial No. 5041150303 UDI 10705037030958 Serial No. 5041150311 UDI 10705037030958 Serial No. 5041150308 UDI 10705037030958 Serial No. 5041150327 UDI 10705037030958 Serial No. 5041150325 UDI 10705037030958 Serial No. 5041150329 UDI 10705037030958 Serial No. 5041150330 UDI 10705037030958 Serial No. 5041150331 UDI 10705037030958 Serial No. 5041150333 UDI 10705037030958 Serial No. 5041150334 UDI 10705037030958 Serial No. 5041150341 UDI 10705037030958 Serial No. 5041150342 UDI 10705037030958 Serial No. 5041150343 UDI 10705037030958 Serial No. 5041150344 UDI 10705037030958 Serial No. 5041150345 UDI 10705037030958 Serial No. 5041150346 UDI 10705037030958 Serial No. 5041150347 UDI 10705037030958 Serial No. 5041150348 UDI 10705037030958 Serial No. 5041150349 UDI 10705037030958 Serial No. 5041150350 UDI 10705037030958 Serial No. 5041160377
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVOTECH™ 50004Advanced Sterilization Products Services Inc. · ACCESSORIES, CLEANING, FOR ENDOSCOPE1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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