CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report

Capnostream20 (US) M W/Printer recalled by Oridion Medical 1987

Oridion Medical 1987 is recalling Capnostream20 (US) M W/Printer, distributed nationwide in the US. The recall was initiated on 31 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesB300001010 B300001017 B300001011 B300001056 B300001135 B300001270 B300001318 B300001326 B300001439 B300001396 B300001422 B300001323 B300001327 B300001328 B300001332 B300001264 B500001508 B500001470 B500001471 B500001509 B500001524 B300001404 B300001398 B300001377 B300001386 B300001107 B300001212 B300001308 B300001314 B300001016 B300001128 B300001235 B300001285 B300001291 B300001258 B500001647 B500001731 B500001711 B500001723 B500001735 B300001412 B500001717 B500001732 B300001137 B300001146 B300001147 B300001352 B300001393 B300001408 B500001517 B300001302 B500001827 B500001830 B500001832 B500001839 B500001845 B500001856 B500001858 B500001859 B500001860 B500001861 B500001864 B500001866 B500001868 B500001869 B500001871 B500001875 B500001876 B500001879 B500001881 B500001882 B500001884 B500001886 B500001887 B500001888 B500001889 B500001891 B500001895 B500001896 B500001904 B500001906 B500001907 B500001908 B500001910 B500001911 B500001924 B500001930 B500001932 B500001933 B500001934 B500001935 B500001939 B500001944 B500001954 B500001957 B500001958 B500001961 B500001963 B500001965 B500001967 B500001968 B500001970 B500001971 B500001973 B500001974 B500001978 B500001981 B500001983 B500001986 B500001987 B500001988 B500001990 B500001991 B500001992 B500001994 B500001995 B500001996 B500001997 B500001998 B500001999 B500002000 B500002001 B500002002 B500002003 B500002004 B500002005 B500002006 B500002007 B500002008 B500002010 B500002012 B500002015 B300001363 B500001857 B500001863 B500001877 B500001880 B500001834 B500001848 B300001036 B300001117 B300001138 B300001271 B300001104 B300001158 B300001202 B300001281 B300001321 B300001330 B300001331 B300001354 B300001375 B300001392 B300001082 B300001142 B300001169 B300001200 B300001224 B500001472 B500001473 B500001474 B300001402 B500001556 B500001842 B500001865 B500001878 B500001899 B500001916 B500001952 B500001475 B500001512 B500002092 B500002105 B500002147 B500001966 B500002060 B500002072 B500002074 B500002088 B500002099 B500002106 B500001855 B500002112 B500002124 B500002164 B500002165 B500002166 B500002169 B500002172 B500002180 B500002181 B500002188 B500002226 B500002098 B500002114 B500002115 B500002118 B500002123 B500002125 B500002167 B500002193 B500002195 B500002197 B500002090 B500002093 B500002096 B500001476 B200001385 B200001410 B500001477 B500001520 B500001850 B500002051 B500002062 B500002089 B500002094 B500002100 B500002104 B500002111 B500002113 B500002117 B500002119 B500002121 B500002129 B500002136 B500002138 B500002139 B500002158 B500002325 B500002368 B500002384 B500002391 B500002097 B500001607 B500002317 B500002322 B500002332 B500002184 B500002091 B500002122 B500002133 B500002154 B500002373 B500002086 B500002095 B300001060 B300001061 B500002110 B500002142 B500002144 B500002149 B500002152 B500002418 B500002141 B500002319 B500002346 B500002318 B500002333 B500002116 B500002120 B500002151 B500002338 B500002048 B500002375 B500002393 B500002400 B500002403 B500002412 B500002101 B500002102 B500002107 B500002140 B500002143 B500002153 B500002314 B500002315 B500002316 B500002320 B500002323 B500002324 B500002326 B500002331 B500002335 B500002339 B500002340 B500002341 B500002343 B500002344 B500002345 B500002348 B500002367 B500002370 B500002380 B500002381 B500002382 B500002383 B500002385 B500002386 B500002387 B500002388 B500002389 B500002397 B500002399 B500002401 B500002402 B500002405 B500002407 B500002416 B500002511 B500002526 B500002527 B500002537 B500002540 B500002542 B500002544 B500002552 B500002553 B500002555 B500002557 B500002559 B500002563 B500002572 B500002576 B500002579 B500002585 B500002589 B500002603 B500002328 B500002334 B500002374 B500002398 B500002321 B500002330 B500002390 B500002449 B500002486 B500002488 B500002491 B500002494 B500002499 B500002500 B500002525 B500002536 B500002406 B500002145 B500002690 B500002747 B500002749 B500002755 B500002757 B500002758 B500002761 B500002769 B500002770 B500002772 B500002776 B500002781 B500002782 B500002783 B500002785 B500002790 B500002792 B500002602 B500002608 B500002108 B500002183 B500002501 B500002131 B500002472 B500002580 B500002582 B500002586 B500002587 B500002489 B500002495 B500002541 B500002575 B500002578 B500002548 B500002479 B500002474 B500002543 B500002556 B500002592 B500002137 B500002604 B500002609 B500002615 B500002634 B500002676 B500002732 B500002733 B500002738 B500002741 B500002742 B500002744 B500002745 B500002748 B500002753 B500002760 B500002762 B500002768 B500002771 B500002775 B500002777 B500002778 B500002779 B500002780 B500002784 B500002787 B500002788 B500002789 B539112855 B541112863 B541112864 B541112866 B541112878 B541112882 B541112883 B542112862 B542112887 B542112888 B542112891 B542112895 B542112896 B542112898 B542112901 B542112909 B542112918 B542112922 B542112923 B542112933 B542112934 B542112935 B500002763 B542112894 B542112926 B500002134 B500002155 B539112854 B541112885 B542112892 B542112903 B542112905 B547112959 B547112965 B547112968 B547112971 B547112980 B547112981 B547112982 B547112984 B547112987 B547112988 B547112990 B547112991 B547112995 B547112998 B547113008 B547113009 B500002394 B500002396 B500002415 B500002519 B500002052 B500002073 B500002078 B500002126 B500002349 B500002764 B500002791 B523123183 B523123187 B524123194 B500002157 B500002179 B500002254 B500002303 B500002376 B502123069 B502123092 B502123101 B547112983 B523123178 B523123184 B542123441 B542123447 B542123449 B500002066 B502123102 B523123189 B523123192 B542123435 B543123471 B523123177 B523123179 B524123193 B300001334 B545123507 B300001033

Quantity recalled500

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0029-2019
FDA event ID: 80895
Recalling firm: Oridion Medical 1987, Jerusalem
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2018
FDA classified: 3 Oct 2018
Reported: 10 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 Jul 2018	Recall initiated by company
3 Oct 2018	Classified by FDA	+64 days
10 Oct 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Capnostream20 (US) M W/PRINTER, Part Number CS08659

Where it was distributed

The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

Which lots are affected?

B300001010 B300001017 B300001011 B300001056 B300001135 B300001270 B300001318 B300001326 B300001439 B300001396 B300001422 B300001323 B300001327 B300001328 B300001332 B300001264 B500001508 B500001470 B500001471 B500001509 B500001524 B300001404 B300001398 B300001377 B300001386 B300001107 B300001212 B300001308 B300001314 B300001016 B300001128 B300001235 B300001285 B300001291 B300001258 B500001647 B500001731 B500001711 B500001723 B500001735 B300001412 B500001717 B500001732 B300001137 B300001146 B300001147 B300001352 B300001393 B300001408 B500001517 B300001302 B500001827 B500001830 B500001832 B500001839 B500001845 B500001856 B500001858 B500001859 B500001860 B500001861 B500001864 B500001866 B500001868 B500001869 B500001871 B500001875 B500001876 B500001879 B500001881 B500001882 B500001884 B500001886 B500001887 B500001888 B500001889 B500001891 B500001895 B500001896 B500001904 B500001906 B500001907 B500001908 B500001910 B500001911 B500001924 B500001930 B500001932 B500001933 B500001934 B500001935 B500001939 B500001944 B500001954 B500001957 B500001958 B500001961 B500001963 B500001965 B500001967 B500001968 B500001970 B500001971 B500001973 B500001974 B500001978 B500001981 B500001983 B500001986 B500001987 B500001988 B500001990 B500001991 B500001992 B500001994 B500001995 B500001996 B500001997 B500001998 B500001999 B500002000 B500002001 B500002002 B500002003 B500002004 B500002005 B500002006 B500002007 B500002008 B500002010 B500002012 B500002015 B300001363 B500001857 B500001863 B500001877 B500001880 B500001834 B500001848 B300001036 B300001117 B300001138 B300001271 B300001104 B300001158 B300001202 B300001281 B300001321 B300001330 B300001331 B300001354 B300001375 B300001392 B300001082 B300001142 B300001169 B300001200 B300001224 B500001472 B500001473 B500001474 B300001402 B500001556 B500001842 B500001865 B500001878 B500001899 B500001916 B500001952 B500001475 B500001512 B500002092 B500002105 B500002147 B500001966 B500002060 B500002072 B500002074 B500002088 B500002099 B500002106 B500001855 B500002112 B500002124 B500002164 B500002165 B500002166 B500002169 B500002172 B500002180 B500002181 B500002188 B500002226 B500002098 B500002114 B500002115 B500002118 B500002123 B500002125 B500002167 B500002193 B500002195 B500002197 B500002090 B500002093 B500002096 B500001476 B200001385 B200001410 B500001477 B500001520 B500001850 B500002051 B500002062 B500002089 B500002094 B500002100 B500002104 B500002111 B500002113 B500002117 B500002119 B500002121 B500002129 B500002136 B500002138 B500002139 B500002158 B500002325 B500002368 B500002384 B500002391 B500002097 B500001607 B500002317 B500002322 B500002332 B500002184 B500002091 B500002122 B500002133 B500002154 B500002373 B500002086 B500002095 B300001060 B300001061 B500002110 B500002142 B500002144 B500002149 B500002152 B500002418 B500002141 B500002319 B500002346 B500002318 B500002333 B500002116 B500002120 B500002151 B500002338 B500002048 B500002375 B500002393 B500002400 B500002403 B500002412 B500002101 B500002102 B500002107 B500002140 B500002143 B500002153 B500002314 B500002315 B500002316 B500002320 B500002323 B500002324 B500002326 B500002331 B500002335 B500002339 B500002340 B500002341 B500002343 B500002344 B500002345 B500002348 B500002367 B500002370 B500002380 B500002381 B500002382 B500002383 B500002385 B500002386 B500002387 B500002388 B500002389 B500002397 B500002399 B500002401 B500002402 B500002405 B500002407 B500002416 B500002511 B500002526 B500002527 B500002537 B500002540 B500002542 B500002544 B500002552 B500002553 B500002555 B500002557 B500002559 B500002563 B500002572 B500002576 B500002579 B500002585 B500002589 B500002603 B500002328 B500002334 B500002374 B500002398 B500002321 B500002330 B500002390 B500002449 B500002486 B500002488 B500002491 B500002494 B500002499 B500002500 B500002525 B500002536 B500002406 B500002145 B500002690 B500002747 B500002749 B500002755 B500002757 B500002758 B500002761 B500002769 B500002770 B500002772 B500002776 B500002781 B500002782 B500002783 B500002785 B500002790 B500002792 B500002602 B500002608 B500002108 B500002183 B500002501 B500002131 B500002472 B500002580 B500002582 B500002586 B500002587 B500002489 B500002495 B500002541 B500002575 B500002578 B500002548 B500002479 B500002474 B500002543 B500002556 B500002592 B500002137 B500002604 B500002609 B500002615 B500002634 B500002676 B500002732 B500002733 B500002738 B500002741 B500002742 B500002744 B500002745 B500002748 B500002753 B500002760 B500002762 B500002768 B500002771 B500002775 B500002777 B500002778 B500002779 B500002780 B500002784 B500002787 B500002788 B500002789 B539112855 B541112863 B541112864 B541112866 B541112878 B541112882 B541112883 B542112862 B542112887 B542112888 B542112891 B542112895 B542112896 B542112898 B542112901 B542112909 B542112918 B542112922 B542112923 B542112933 B542112934 B542112935 B500002763 B542112894 B542112926 B500002134 B500002155 B539112854 B541112885 B542112892 B542112903 B542112905 B547112959 B547112965 B547112968 B547112971 B547112980 B547112981 B547112982 B547112984 B547112987 B547112988 B547112990 B547112991 B547112995 B547112998 B547113008 B547113009 B500002394 B500002396 B500002415 B500002519 B500002052 B500002073 B500002078 B500002126 B500002349 B500002764 B500002791 B523123183 B523123187 B524123194 B500002157 B500002179 B500002254 B500002303 B500002376 B502123069 B502123092 B502123101 B547112983 B523123178 B523123184 B542123441 B542123447 B542123449 B500002066 B502123102 B523123189 B523123192 B542123435 B543123471 B523123177 B523123179 B524123193 B300001334 B545123507 B300001033

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

35 other products · FDA event 80895

This product is part of a recall event; the main page for the event is Capnostream20 M Adult ICU (CPM), CS08654RA recalled.

Reported	Class	Recall	Company	Reason	Where
10 Oct 2018	CLASS II	Capnostream20 M Adult ICU (CPM), CS08654RA recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N W/printer - Rohs, Cs08658 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N W/printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) N W/Printer Refurbished recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (intl) N W/printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (INTL) M, CS08654 recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) N Refurbished, CS78652 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 M NICU (CPM), CS08654RN recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (intl) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N W/printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (us) N W/printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N W/printer - Rohs, Cs051cov recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) M W/Printer Refurbished, CS78660 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M W/Printer Refurbished recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 N Cyvital, CS08799 recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US)M Refurbished recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M TO Masimo recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) M Refurbished, CS78654 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) N W/Printer Refurbished, CS78658 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M W/Printer TO Masimo recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N W/printer - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N W/printer - Rohs, Cs08658 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N W/printer - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) N Refurbished recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 N W/Printer Cyvital, CS08798 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (cov-intl) N W/printer Rohs, Cs051cov recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 M W/Printer Cyvital, CS08796 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) M W/Printer, CS08660 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (us) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide

More recalls from Oridion Medical 1987

All 46

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide