CAPNOSTREAM 20P (US) N - ROHS
Medical device recall Z-0023-2019. Published in FDA’s Enforcement Report on Oct 10, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 10, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 2976 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
2976, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
PA07170091 PA07170092 PA07170093 PA07170094 PA07170095 PA07170096 PA07170097 PA07170098 PA07170099 PA07170100 PA07170101 PA07170102 PA07170103 PA07170104 PA07170106 PA07170107 PA07170108 PA07170109 PA07170110 PA07170111 PA07170112…
Every code shown here, 1,991 characters
PA07170091 PA07170092 PA07170093 PA07170094 PA07170095 PA07170096 PA07170097 PA07170098 PA07170099 PA07170100 PA07170101 PA07170102 PA07170103 PA07170104 PA07170106 PA07170107 PA07170108 PA07170109 PA07170110 PA07170111 PA07170112 PA07170113 PA07170114 PA07170115 PA07170116 PA07170117 PA07170118 PA07170119 PA09170121 PA09170123 PA09170124 PA09170126 PA09170127 PA09170128 PA09170129 PA09170130 PA09170131 PA09170132 PA09170133 PA09170134 PA09170135 PA09170136 PA09170137 PA09170138 PA09170139 PA09170140 PA09170141 PA09170142 PA09170143 PA09170144 PA09170145 PA09170146 PA09170147 PA09170148 PA09170149 PA09170150 PA09170151 PA09170152 PA09170153 PA09170154 PA09170155 PA09170156 PA09170157 PA09170158 PA09170159 PA09170160 PA10170161 PA10170162 PA10170163 PA10170164 PA10170165 PA10170166 PA10170167 PA10170168 PA10170169 PA10170170 PA10170172 PA10170173 PA10170174 PA10170175 PA10170176 PA10170177 PA10170178 PA10170180 PA10170181 PA10170182 PA10170183 PA10170184 PA10170185 PA10170186 PA10170187 PA10170188 PA10170189 PA10170190 PA10170191 PA10170192 PA10170194 PA10170195 PA10170196 PA10170197 PA10170198 PA10170199 PA10170200 PA10170201 PA10170202 PA10170203 PA10170205 PA10170206 PA10170207 PA10170208 PA10170209 PA10170210 PA10170211 PA10170212 PA52160061 PA52160062 PA52160063 PA52160064 PA52160065 PA52160066 PA52160067 PA52160068 PA52160069 PA52160070 PA52160071 PA52160072 PA52160073 PA52160074 PA52160075 PA52160076 PA52160077 PA52160078 PA52160079 PA52160080 PA52160081 PA52160082 PA52160083 PA52160084 PA52160085 PA52160086 PA52160087 PA52160088 PA52160089 PA52160090 PA10170278 PA11170344 PA11170359 PA11170392 PA11170395 PA11170397 PA11170423 PA11170427 PA11170430 PA11170445 PA11170449 PA11170450 PA11170451 PA11170455 PA11170460 PA11170467 PA11170469 PA12170481 PA12170485 PA12170487 PA12170488 PA12170493 PA12170499 PA12170500 PA12170503 PA12170504 PA12170515 PA12170524 PA12170527 PA12170530 PA12170535 PA12170545 PA12170550 PA12170552 PA12170553 PA12170557 PA12170559…
FDA’s list runs to 32,736 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 31, 2018.
- FDA classified it on Oct 3, 2018.
- FDA’s Enforcement Report published it on Oct 10, 2018.
- FDA terminated it on Sep 20, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Oridion Medical 1987 Ltd., of Jerusalem, Israel.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 32,736 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.