Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including…
Medical device recall Z-1208-2018. Published in FDA’s Enforcement Report on Apr 4, 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 Apr 4, 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 46 states named
- 15,885 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?
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.
15,885, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1349MM0001 UDI: 20884521700861 1349MM0002 1349MM0003 1349MM0004 1349MM0005 1349MM0006 1349MM0007 1349MM0008 1349MM0009 1349MM0010 1349MM0011 1349MM0012 1349MM0013 1349MM0014 1349MM0015 1349MM0016 1349MM0017 1349MM0018…
Every code shown here, 1,994 characters
Serial Numbers: 1349MM0001 UDI: 20884521700861 1349MM0002 1349MM0003 1349MM0004 1349MM0005 1349MM0006 1349MM0007 1349MM0008 1349MM0009 1349MM0010 1349MM0011 1349MM0012 1349MM0013 1349MM0014 1349MM0015 1349MM0016 1349MM0017 1349MM0018 1349MM0019 1349MM0020 1349MM0021 1349MM0022 1349MM0023 1349MM0024 1349MM0025 1349MM0026 1349MM0027 1349MM0028 1349MM0029 1349MM0030 1349MM0031 1349MM0032 1349MM0033 1349MM0034 1349MM0035 1349MM0036 1349MM0037 1349MM0038 1349MM0039 1349MM0040 1349MM0041 1349MM0042 1349MM0043 1349MM0044 1349MM0045 1349MM0046 1349MM0047 1349MM0048 1349MM0049 1349MM0050 1349MM0051 1349MM0052 1349MM0053 1349MM0054 1349MM0055 1349MM0056 1349MM0057 1349MM0058 1349MM0059 1349MM0060 1349MM0061 1349MM0062 1349MM0063 1349MM0064 1349MM0065 1349MM0066 1349MM0067 1349MM0068 1349MM0069 1349MM0070 1349MM0071 1349MM0072 1349MM0073 1349MM0074 1349MM0075 1349MM0076 1349MM0077 1349MM0078 1349MM0079 1349MM0080 1349MM0081 1349MM0082 1349MM0083 1349MM0084 1349MM0085 1349MM0086 1349MM0087 1349MM0088 1349MM0089 1349MM0090 1349MM0091 1349MM0092 1349MM0093 1349MM0094 1349MM0095 1349MM0096 1349MM0097 1349MM0098 1349MM0099 1349MM0100 1349MM0101 1349MM0102 1349MM0103 1349MM0104 1349MM0105 1349MM0106 1349MM0107 1349MM0108 1349MM0109 1349MM0110 1349MM0111 1349MM0112 1349MM0113 1349MM0114 1349MM0115 1349MM0116 1349MM0117 1349MM0118 1349MM0119 1349MM0120 1349MM0121 1349MM0122 1349MM0123 1349MM0124 1349MM0125 1349MM0126 1349MM0127 1349MM0128 1349MM0129 1349MM0130 1349MM0131 1349MM0132 1349MM0133 1349MM0134 1349MM0135 1349MM0136 1349MM0137 1349MM0138 1349MM0139 1349MM0140 1349MM0141 1349MM0142 1349MM0143 1349MM0144 1349MM0145 1349MM0146 1349MM0147 1349MM0148 1349MM0149 1349MM0150 1349MM0151 1349MM0152 1349MM0153 1349MM0154 1349MM0155 1349MM0156 1349MM0157 1349MM0158 1349MM0159 1349MM0160 1349MM0161 1349MM0162 1349MM0163 1349MM0164 1349MM0165 1349MM0166 1349MM0167 1349MM0168 1349MM0169 1349MM0170 1349MM0171 1349MM0172 1349MM0173 1349MM0174 1349MM0175 1349MM0176 1349MM0177 1349MM0178…
FDA’s list runs to 187,944 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 - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam
The states and territories these words name
46 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 Nov 21, 2017.
- FDA classified it on Mar 27, 2018.
- FDA’s Enforcement Report published it on Apr 4, 2018.
- FDA terminated it on Jul 10, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien LLC, of North Haven, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 187,944 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.