Recall Record

Carlsbad, CA, United States

Respironics California, LLC recalls

8 recalls recorded since 2018, most recently on 28 February 2022. 7 are listed as ongoing. Status and classification are as published by the FDA.

Recalls8
Ongoing (FDA)7
Terminated or completed1
Class I (FDA)3

Ongoing Class I Medical devices

Recall started
28 February 2022
Reason
Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
Distribution
Worldwide distribution US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Afghanistan
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0909-2022, Z-0908-2022, Z-0907-2022

Ongoing Class I Medical devices

Recall started
24 January 2022
Reason
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Distribution
U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0663-2022, Z-0662-2022

Ongoing Class I Medical devices

Recall started
18 June 2021
Reason
It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
Distribution
Worldwide Distribution: U.S (nationwide) to states of.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and O.U.S. countries of: Andorra, United Ara
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2074-2021, Z-2073-2021

Ongoing Class II Medical devices

Recall started
6 January 2021
Reason
Due to unqualified "design verification" batteries being shipped to customers.
Distribution
U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
Initiated
Voluntary: Firm initiated
Recall number
Z-1137-2021

Ongoing Class II Medical devices

Recall started
2 November 2020
Reason
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
Distribution
Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Den
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0910-2021, Z-0907-2021, Z-0903-2021, Z-0904-2021, Z-0911-2021, Z-0914-2021, Z-0912-2021, Z-0909-2021, Z-0917-2021, Z-0902-2021, Z-0915-2021, Z-0908-2021 and 4 more

Terminated Class II Medical devices

Recall started
30 October 2020
Terminated
19 September 2024
Reason
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, W
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0887-2021, Z-0894-2021, Z-0885-2021, Z-0886-2021, Z-0889-2021, Z-0890-2021, Z-0896-2021, Z-0899-2021, Z-0892-2021, Z-0897-2021, Z-0901-2021, Z-0893-2021 and 5 more

Ongoing Class II Medical devices

Recall started
5 March 2020
Reason
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
Distribution
U.S.: CO, PA, AZ, OH, MT, AR, FL, NC, KS, IL, CA, HI, MD, SC, WY, OR, NY, NE, OK, MN, UT, ND, LA, IN, AL, AK, WV, GA, WI, MI, VA, NJ, TX, WA, SD, KY, TN, MS, MO, DE, MA, VT, CT, IA, NV, ID, ME, NM, DC, NH, VI, RI, PR. O.U.S.: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canad
Initiated
Voluntary: Firm initiated
Recall number
Z-1622-2020

Ongoing Class II Medical devices

Recall started
11 September 2019
Reason
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
Distribution
US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1152-2020, Z-1154-2020, Z-1153-2020, Z-1155-2020

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.