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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75290

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 27, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Advanced Sterilization Products

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0965-2017
Recall number
Z-0965-2017
Initiated
September 27, 2016
Classification
Class II
Status
Terminated
Quantity
107 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US Nationwide Distribution.