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

Capnostream 20 (intl) N recalled by Oridion Medical 1987

Oridion Medical 1987 is recalling Capnostream 20 (intl) N, 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 codesB200001301 B200001306 B200001625 B200002065 B200002206 B200001982 B200002098 B200001475 B200002000 B200001865 B200001835 B200001944 B200002030 B200002202 B200001012 B200001314 B200001866 B200002032 B200002139 B200001723 B200001908 B200001926 B200001703 B200001755 B200001500 B200001763 B200001519 B200001653 B200001655 B200001661 B200001670 B200001722 B400001155 B400002342 B200001729 B400002520 B400002480 B400002505 B200001802 B400002492 B400002518 B400002521 B400002542 B400002728 B400002713 B400002800 B400002813 B451113083 B450113072 B406123152 B406123163 B408123213 B400002450 B410123265 B420123420 B420123421 B400002844 B440112971 B447123778 B449123886 B449123889 B449123899 B449123915 B449123917 B449123919 B449123920 B449123921 B449123922 B449123924 B449123925 B449123927 B449123930 B449123931 B449123936 B449123938 B449123939 B449123963 B449123967 B450123979 B450123982 B450123983 B450123985 B450123989 B450123991 B450123994 B450123995 B450123998 B450123999 B450124000 B450124001 B450124003 B451124006 B415123322 B420123441 B445123646 B448123832 B405134172 B405134174 B408134285 B408134293 B408134300 B409134335 B409134341 B409134366 B409134370 B409134372 B409134373 B409134374 B410134375 B410134376 B410134377 B410134378 B410134379 B410134380 B410134381 B410134383 B410134384 B410134385 B410134386 B410134388 B410134389 B410134390 B410134391 B410134392 B410134393 B410134395 B410134396 B410134397 B410134398 B410134399 B410134402 B410134403 B410134404 B410134406 B410134407 B410134408 B410134409 B410134410 B410134412 B410134413 B409134371 B410134456 B411134457 B411134458 B411134460 B411134461 B411134463 B411134464 B411134465 B411134467 B411134470 B411134472 B411134473 B411134475 B411134477 B411134478 B411134479 B411134480 B411134481 B411134482 B411134483 B411134484 B411134487 B411134488 B411134490 B411134492 B411134493 B411134495 B411134496 B411134497 B411134498 B411134499 B411134501 B411134502 B415123331 B411134468 B412134577 B412134579 B412134580 B413134639 B413134664 B412134575 B412134583 B412134587 B412134594 B412134598 B412134608 B412134613 B413134627 B418135262 B419135293 B419135320 B419135366 B421135540 B422135619 B422135630 B422135631 B422135643 B422135647 B422135658 B422135661 B422135664 B422135668 B422135671 B422135674 B422135678 B422135680 B422135683 B426136203 B426136204 B426136205 B426136206 B426136207 B426136208 B426136209 B426136210 B426136211 B426136212 B426136213 B426136214 B426136215 B426136216 B426136217 B426136218 B426136219 B426136220 B426136221 B426136222 B426136223 B426136224 B426136225 B451113128 B411134485 B426136202 B427136343 B428136402 B429136523 B429136527 B429136564 B429136566 B429136579 B430136649 B449123898 B416135083 B450123978

Quantity recalled245

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-0036-2019
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

CAPNOSTREAM 20 (INTL) N, Part Number CS08652

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?

B200001301 B200001306 B200001625 B200002065 B200002206 B200001982 B200002098 B200001475 B200002000 B200001865 B200001835 B200001944 B200002030 B200002202 B200001012 B200001314 B200001866 B200002032 B200002139 B200001723 B200001908 B200001926 B200001703 B200001755 B200001500 B200001763 B200001519 B200001653 B200001655 B200001661 B200001670 B200001722 B400001155 B400002342 B200001729 B400002520 B400002480 B400002505 B200001802 B400002492 B400002518 B400002521 B400002542 B400002728 B400002713 B400002800 B400002813 B451113083 B450113072 B406123152 B406123163 B408123213 B400002450 B410123265 B420123420 B420123421 B400002844 B440112971 B447123778 B449123886 B449123889 B449123899 B449123915 B449123917 B449123919 B449123920 B449123921 B449123922 B449123924 B449123925 B449123927 B449123930 B449123931 B449123936 B449123938 B449123939 B449123963 B449123967 B450123979 B450123982 B450123983 B450123985 B450123989 B450123991 B450123994 B450123995 B450123998 B450123999 B450124000 B450124001 B450124003 B451124006 B415123322 B420123441 B445123646 B448123832 B405134172 B405134174 B408134285 B408134293 B408134300 B409134335 B409134341 B409134366 B409134370 B409134372 B409134373 B409134374 B410134375 B410134376 B410134377 B410134378 B410134379 B410134380 B410134381 B410134383 B410134384 B410134385 B410134386 B410134388 B410134389 B410134390 B410134391 B410134392 B410134393 B410134395 B410134396 B410134397 B410134398 B410134399 B410134402 B410134403 B410134404 B410134406 B410134407 B410134408 B410134409 B410134410 B410134412 B410134413 B409134371 B410134456 B411134457 B411134458 B411134460 B411134461 B411134463 B411134464 B411134465 B411134467 B411134470 B411134472 B411134473 B411134475 B411134477 B411134478 B411134479 B411134480 B411134481 B411134482 B411134483 B411134484 B411134487 B411134488 B411134490 B411134492 B411134493 B411134495 B411134496 B411134497 B411134498 B411134499 B411134501 B411134502 B415123331 B411134468 B412134577 B412134579 B412134580 B413134639 B413134664 B412134575 B412134583 B412134587 B412134594 B412134598 B412134608 B412134613 B413134627 B418135262 B419135293 B419135320 B419135366 B421135540 B422135619 B422135630 B422135631 B422135643 B422135647 B422135658 B422135661 B422135664 B422135668 B422135671 B422135674 B422135678 B422135680 B422135683 B426136203 B426136204 B426136205 B426136206 B426136207 B426136208 B426136209 B426136210 B426136211 B426136212 B426136213 B426136214 B426136215 B426136216 B426136217 B426136218 B426136219 B426136220 B426136221 B426136222 B426136223 B426136224 B426136225 B451113128 B411134485 B426136202 B427136343 B428136402 B429136523 B429136527 B429136564 B429136566 B429136579 B430136649 B449123898 B416135083 B450123978

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 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	Capnostream20 (US) M W/Printer recalled by Oridion Medical 1987	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 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
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16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide