Z-0965-2017Class II

EVOTECH Endoscope Cleaner and Reprocessor System 208V

Name: Z-0965-2017 EVOTECH Endoscope Cleaner and Reprocessor System 208V
Creator: Advanced Sterilization Products
Published: 2016-09-27
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2016-09-27 / Terminated / root cause: manufacturing process

FDA source

Advanced Sterilization Products began a recall of EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is... on 2016-09-27. FDA classified it as Class II and gives the reason as "Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0965-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-27
Posted: 2017-01-09
Terminated: 2017-04-17
Recalling firm: Advanced Sterilization Products
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 (>60C} semi-critical endoscopes.
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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].
Quantity in commerce: 107 units
Distribution: US Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0965-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0965-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code FEB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)