CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
nGenuity Patient Monitor with Capnography recalled
Criticare Technologies is recalling nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-St-us, CAT 8100E1-US, CAT, distributed nationwide in the US. The recall was initiated on 6 May 2026 and the FDA has classified it as Class II.
Check your package
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-3253-2026
- FDA event ID
- 99545
- Recalling firm
- Criticare Technologies, Warwick, RI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 May 2026
- FDA classified
- 22 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 6 May 2026 | Recall initiated by company | |
| 22 Sep 2026 | Classified by FDA | +139 days |
| 30 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
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
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R
Where it was distributed
US Nationwide distribution including in the states and territory of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and Puerto Rico.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Why was it recalled?
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Which lots are affected?
UDI-DI +B4388100EP1US02 All units with CO2 option SN beginning with 424, 125, 225, 325, 425, 126, 226, 326, 426, date range 2024-1st qt 2026
Where was it sold?
US Nationwide distribution including in the states and territory of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and Puerto Rico.
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 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |