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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Flushing Pump OFP2

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 Class 2 Device Recall Olympus Flushing Pump OFP2see related information
Date Initiated by FirmAugust 23, 2024
Date PostedOctober 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0229-2025
Recall Event ID 95440
510(K)NumberK100899 
Product Classification Pump, air, non-manual, for endoscope - Product Code FEQ
ProductOlympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Code Information UDI-DI: 15019778003191; Serial Numbers: 22324681 22324838 22324815 22324817 22324668 22324816 22324667 22324666 22324837 22325205 22325319 22325320 22325005 22324922 22325318 22325008 22324932 22325207 22324931 22325306 22325593 22325317 22325208 22325315 22325316 22325409 22325411 22325305 22325304 22325408 22325410 22324923 22325303 22325592 22325579 22326433 22325665 22326420 22326435 22326299 22325582 22325594 22326281 22324536 22326418 22326419 22325580 22325595 22325651 22326417 22325650 22326434 22326436 22325649 22326495 22325581 22326284 22326283 22325583 22326309 22326308 22326282 22326892 22326891 22326503 22326599 22326895 22326597 22326897 22326608 22326506 22326894 22326598 22326496 22327325 22327322 22326607 22326497 22327327 22326600 22327323 22326505 22329514 22329504 22329332 22329506 22329503 22329507 22329497 22329467 22329513 22329341 22329343 22329331 22329751 22329596 22329752 22329605 22329608 22329753 22329610 22331369 22331173 22331037 22331153 22331035 22331156 22331341 22331342 22331362 22331343 22331155 22331172 22326893 22331152 22331904 22331903 22331458 22331556 22331561 22331546 22331558 22331461 22331460 22331459 22331457 22331477 22331345 22331557 22331756 22331760 22331559 22331560 22331759 22331758 22331851 22331849 22331846 22331845 22331847 22331848 22331786 22331755 22332160 22332318 22332283 22332484 22332187 22332284 22332316 22332483 22332346 22332321 22332320 22332159 22332285 22332185 22332184 22332186 22332161 22332158 22332156 22332188 22332488 22332486 22332490 22332489 22332345 22332317 22332183 22332312 22332281 22332060 22332035 22332036 22332059 22332709 22331932 22332718 22332061 22331908 22332861 22332032 22332624 22333316 22333194 22333301 22333433 22333200 22333300 22333296 22333177 22333432 22333429 22333434 22333298 22333318 22333299 22333315 22333430 22333319 22333435 22333431 22333428 22333201 22333175 22332981 22332980 22332860 22332869 22332957 22332951 22332870 22332863 22332949 22332954 22332956 22333067 22333088 22333089 22333066 22333064 22332868 22333180 22410039 22410042 22410036 22410038 22410041 22410217 22410218 22410040 22410216 22410215 22410214 22410220 22410213 22410037 22333603 22333599 22333605 22333297 22331850 22333602 22333179 22333601 22333604 22333195 22333606 22410904 22410474 22410725 22410723 22410727 22410724 22410726 22410835 22410833 22410446 22410545 22410544 22410704 22410834 22410840 22410838 22411043 22410473 22410542 22410476 22410543 22410445 22410540 22410538 22331757 22410541 22410706 22410702 22410477 22410705 22410475 22410448 22410539 22410384 22410354 22410355 22410444 22410352 22410478 22410351 22410356 22332622 22332621 22332286 22332287 22411047 22410836 22411771 22411045 22411046 22411790 22411773 22411772 22411770 22410992 22411044 22412004 22411953 22412266 22412293 22412292 22412099 22412283 22412294 22412097 22412281 22412268 22412267 22412098 22412291 22412111 22412282 22412100 22412269 22411860 22412005 22412110 22411861 22411951 22412002 22412003 22411863 22412102 22412357 22412356 22412354 22412381 22412355 22412353 22412382 22412380 22412461 22412573 22412571 22412490 22412583 22412557 22412585 22412584 22412462 22412822 22412487 22412488 22412587 22412586 22412489 22412556 22412554 22412492 22412553 22412486 22412480 22412481 22412485 22412484 22412821 22412850 22412849 22412459 22412458 22412460 22412823 22412847 22412824 22412825 22413151 22412972 22413167 22412971 22412969 22412974 22412968 22413169 22413145 22412962 22412944 22412970 22412965 22413168 22412964 22412963 22413166 22412946 22413171 22413173 22413147 22413174 22412967 22413149 22413179 22412966 22412943 22413146 22413150 22412846 22412911 22412928 22412912 22412265 22412975 22412907 22412941 22412930 22412935 22412909 22412908 22412932 22412933 22412910 22413255 22413148 22413259 22413258 22413175 22413177 22413170 22413873 22413814 22413929 22413812 22413813 22413767 22413774 22413523 22413743 22413775 22413757 22413520 22413385 22413386 22413529 22413758 22413760 22413741 22413773 22413771
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
FDA Determined
Cause 2		Equipment maintenance
ActionAn URGENT: MEDICAL DEVICE CORRECTION notification letter dated 9/20/24 was sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. The range of affected serial numbers is included at the top of this letter. The serial number is on a label affixed to the back of the OFP-2 pump. An Olympus representative will create a Return Material Authorization for the return of your device to Olympus for an inspection. You may continue to use your OFP-2 pump until an Olympus representative performs the inspection. If the OFP-2 fails the inspection, the OFP-2 will require repair. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0455 c. Complete the form as instructed. 3. If you have further distributed this product, identify your customers, and forward them this notification. 4. Beginning November 2024, please contact Olympus Customer Service at 1-800-848-9024, option 3, to request an Air Switch Assembly Inspection . Olympus will arrange for the return of your device to our Olympus Repair Center at a mutually convenient time. The Olympus representative s record of repair will also serve as the completion record of this action for your facility. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@Olympus.com.
Quantity in Commerce445 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FEQ
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