Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from…
Medical device recall Z-0425-2021. Published in FDA’s Enforcement Report on Nov 18, 2020.
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 Nov 18, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 23,329 units total:. US 12,956; OUS 10,405 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?
In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC 980X3ITDIEC 980X3JADIJJ 980X3SVAIQC 980U3ENASAA 980U1ENDICU 980U1FRDICU 980X3ENDRAC 980X1FRDISS 980A3ENNISB 980X1PLDIPC 980X3SKNISC 980U3ESDIUU 980X1DEDISS 980X3DEDISS 980X3HUNISC 980X3ENDIPP 980X1BGDRAC 980X1ENDRAC 980X1NLDRAC 980A1ENNISB 980X3TRDRAC 980X3CSNISC 980U3ESDIUC 980U1ENASAA 980X1JADIJJ 980X1FRAIQC 980X1ENDIPC 980X1ENNISB 980X1ESDIEC 980X1ITDIEC 980X1PTDIPC 980X1DEDRAC 980X1TRDRAC 980X3RODRAC 980S1ENDICU 980X3RUDRAC 980U1ESDIUU 980U3ESDIUA 980X3SRDRAC 980X1ENDIPP 980U1ESDIUC 980X3ENDIUU 980X3ENDIJI 980X1SKNISC 980X3PTDIPC 980U1ESDIUA 980U3PTDIUNA 980X1DAAGAC 980X1FIAGAC 980X1NOAGAC 980X1SVAGAC 980X3ENAIQC 980X1HUNISC 980X2ENDIUU 980X3ENASAA 980X1ENASAA 980S3ESDIUU 980X1RODRAC 980S1PTDIUNA 980X1SLDRAC 980S1ESDIUU 980S1ESDIUC 980S3ESDIUA 980S1ESDIUA 980S3ESDIUC 980S1FRDICU 980S3ENDICU 980X2ENASAA 980X2ITDIEC 980X1ELAIQC 980X2DEDRAC 980X2FRAIQC 980X2ENNISB 980X2ESDIEC 980A2ENNISB 980X2PLDIPC 980X1ENAIQC 980U1PTDIUNA 980X3ENDISS 980X2ENDISS 980X1HRDRAC 980X3RUDIEC 980U3ENDICU 980X1SRDRAC 980X1ENDIJI 980X2RUDRAC 980X3ENDIPB 980P1ZHNISD 980P3ZHNISD 980C1ZHNISD 980C3ZHNISD 980C2ZHNISD 980N1ZHNISD 980N3ZHNISD 980P2ZHNISD 980X1ENNISC 980U3ENDIUU-LA 980U1ENDIUU-LA
23,329 units total:. US 12,956; OUS 10,405, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
serial Numbers: 35B1300004 35B1300010 35B1300019 35B1300021 35B1300022 35B1300025 35B1300036 35B1300037 35B1300045 35B1300046 35B1300013 35B1300041 35B1300006 35B1300008 35B1300009 35B1300027 35B1300051 35B1300016 35B1300042 35B1300005…
Every code shown here, 1,996 characters
serial Numbers: 35B1300004 35B1300010 35B1300019 35B1300021 35B1300022 35B1300025 35B1300036 35B1300037 35B1300045 35B1300046 35B1300013 35B1300041 35B1300006 35B1300008 35B1300009 35B1300027 35B1300051 35B1300016 35B1300042 35B1300005 35B1300026 35B1300031 35B1300001 35B1300040 35B1300050 35B1300020 35B1300033 35B1300030 35B1300044 35B1300011 35B1300048 35B1300035 35B1300002 35B1300029 35B1300038 35B1300014 35B1300017 35B1300003 35B1300015 35B1400001 35B1300018 35B1300034 35B1300007 35B1300032 35B1300043 35B1400005 35B1400010 35B1400013 35B1400020 35B1400024 35B1400009 35B1400028 35B1400017 35B1400025 35B1400023 35B1400011 35B1400021 35B1400032 35B1400033 35B1400034 35B1400040 35B1400003 35B1400026 35B1400030 35B1400035 35B1400044 35B1400048 35B1400055 35B1400056 35B1400059 35B1400060 35B1400061 35B1400063 35B1400049 35B1400068 35B1400069 35B1400050 35B1400062 35B1400064 35B1400072 35B1400007 35B1400015 35B1400058 35B1400077 35B1400083 35B1400057 35B1400041 35B1400066 35B1400070 35B1400087 35B1400088 35B1400092 35B1400074 35B1400091 35B1400039 35B1400071 35B1400075 35B1400012 35B1400042 35B1400053 35B1400065 35B1400079 35B1400080 35B1400095 35B1400073 35B1400082 35B1400038 35B1400036 35B1400097 35B1400101 35B1400104 35B1400067 35B1400047 35B1400006 35B1400103 35B1400110 35B1400112 35B1400113 35B1400116 35B1400111 35B1400108 35B1400109 35B1400098 35B1400081 35B1400096 35B1400022 35B1400105 35B1400119 35B1400122 35B1400123 35B1400124 35B1400126 35B1400100 35B1400129 35B1400130 35B1400132 35B1400137 35B1400134 35B1400131 35B1400135 35B1400115 35B1400127 35B1400027 35B1400084 35B1400138 35B1400093 35B1400133 35B1400141 35B1400149 35B1400142 35B1400145 35B1400147 35B1400150 35B1400153 35B1400051 35B1400136 35B1400152 35B1400139 35B1400037 35B1400159 35B1400078 35B1400089 35B1400114 35B1400117 35B1400120 35B1400140 35B1400143 35B1400151 35B1400155 35B1400157 35B1400158 35B1400172 35B1400164 35B1400154 35B1400161 35B1400162 35B1400018 35B1400160 35B1400174 35B1400176…
FDA’s list runs to 296,633 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.
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Bolivia, Brazil, Cayman Islands, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Jamaica, Mexico, Nicaragua, Panama, Peru, Uraguay, Honduras, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Taiwan, Korea, Brunei Daruss., Cambodia, Indonesia, Malaysia, Singapore, Thailand, Vietnam, Japan.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Oct 16, 2020.
- FDA classified it on Nov 6, 2020.
- FDA’s Enforcement Report published it on Nov 18, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien Llc, of Mansfield, MA.
- 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 296,633 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
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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.