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PHYSIO-CONTROL, Inc.

Active in EUDAMED
Also registered as Physio-Control Corp.

United Statesfrom SRN EUDAMED FDA SRN US-MF-000000290 FEI 3015876

PHYSIO-CONTROL, Inc. is a medical device manufacturer based in the United States, with 2,291 devices listed in 4 registries (EU Class IIb and I; FDA Class III and II) and 72 FDA recalls as of 12 Nov 2026.

Devices
2,291
Registrations
EUDAMEDFDA
FDA recalls
7222 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • EUDAMED 1,395
  • FDA GUDID 850
  • FDA 510(k) 92
  • FDA PMA 3

A device listed in two registries counts in both.

Device classes
  • EU Class IIb 1,323
  • FDA Class III 688
  • FDA Class II 184
  • EU Class I 24
  • FDA Class I 21
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000000290
  • FDA FEI 3015876
  • DUNS 009251992

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

Catalogue2,291

Newest first, rows 1-50 of 2,291

Search and filter all 2,291 devices
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Rows 1-50 of 2,291

Showing 1-50 of 2,291

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000000290
FDA FEI number
3015876
DUNS number
009251992
EU VAT number
NL 823521 631 B01
EUDAMED status
Active
EUDAMED registered name
PHYSIO-CONTROL, Inc.
Registered address
11811 Willows Road N.E., 98052, Redmond, United States
Phone
+1-800-327-0770
PRRC contact
Valerio Hammes(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 22 Aug 2029

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 011882 0094 Active Supplemented

    Quality management system EU MDR

    Issued
    30 Jul 2026
    Expires
    22 Aug 2029
    Reason
    Add device or group

FDA recalls72

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 7
  • 2018 0
  • 2019 4
  • 2020 3
  • 2021 1
  • 2022 1
  • 2023 11
  • 2024 2
  • 2025 6
  • 2026 2

35 initiated before 2017

Showing the 10 most recent of 72 recalls.

  • 2026

    • 13 Apr 2026 Z-2065-2026 Class II Ongoing Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy. Distribution: US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ,…
      Full distribution text US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.
      Submission number: P160026
    • 21 Jan 2026 Z-1544-2026 Class II Ongoing Due to pediatric defibrillator electrode delamination Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, 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, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan.
      Submission number: P160012

  • 2025

    • 22 Jul 2025 Z-2497-2025 Class II Ongoing Due to required inspections not being performed on products/units that have gone through servicing. Distribution: U.S. Nationwide distribution in the states of CO and MT. Submission number: P160026
    • 22 Jul 2025 Z-2498-2025 Class II Ongoing Due to required inspections not being performed on products/units that have gone through servicing. Distribution: U.S. Nationwide distribution in the states of CO and MT. Submission number: P160026
    • 22 Jul 2025 Z-2499-2025 Class II Ongoing Due to required inspections not being performed on products/units that have gone through servicing. Distribution: U.S. Nationwide distribution in the states of CO and MT. Submission number: P170018
    • 3 Feb 2025 Z-1232-2025 Class II Ongoing Incorrect keypad was incorrectly installed onto a defibrillator/monitor. Distribution: U.S.: WV O.U.S.: N/A Submission number: P160026
    • 21 Jan 2025 Z-1102-2025 Class II Ongoing Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions Distribution: U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and…
      Full distribution text U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.
      Submission number: K240377
    • 21 Jan 2025 Z-1184-2025 Class II Ongoing Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. Distribution: U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MS, NC,…
      Full distribution text U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MS, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WV.
      Submission number: P160026

  • 2024

    • 30 Aug 2024 Z-0230-2025 Class II Ongoing Due to an out of tolerance tool being used on monitor/defibrillator systems. Distribution: U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A Submission number: P160026
    • 9 Aug 2024 Z-0142-2025 Class II Ongoing Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and New Zealand.
      Submission number: K182503
Show the 25 most recent of 72 recalls

  • 2023

    • 6 Nov 2023 Z-0567-2024 Class II Ongoing AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA. Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY,…
      Full distribution text US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
      Submission number: P160026
    • 29 Sep 2023 Z-0296-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0297-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0298-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0299-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0300-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0301-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0302-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0303-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0304-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026
    • 29 Sep 2023 Z-0305-2024 Class II Ongoing Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. Distribution: US Nationwide distribution in the states of AZ, CA, NC, NJ, NY. Submission number: P160026

  • 2022

    • 13 Jan 2022 Z-0745-2022 Class III Terminated Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. Distribution: U.S.: AK Submission number: P160008

  • 2021

    • 14 Jan 2021 Z-1189-2021 Class II Ongoing Due to complaints received regarding missing lid magnets which may result in premature battery depletion. Distribution: Worldwide Distribution to U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS,…
      Full distribution text Worldwide Distribution to U.S.(nationwide): AK, AL, AR, 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, Virgin Island, VT, WA, WI, WV and WY O.U.S. countries of: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Qatar, Saint Barth¿lemy, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
      Submission number: P170018

  • 2020

    • 24 Apr 2020 Z-2359-2020 Class II Terminated Packaging of infant child reduced energy electrodes was not properly sealed. Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA, AZ, NJ, MA, MO, NC, MD, OH, PA, CA, IA, VA, WI, MN, SC, IN, DE, KY, MT, AL, MS, NM, ME, OK, WV, SD, RI, ND, LA, AR, HI, DC, KS, NE, VT, OR, AK, NV, UT, WY, NH, PR, ID, and the countries of CA, ZA, TW, AU, JP, HK, MA, NZ, SG, BR, NL, PA, SA, AR, CL, TH, SV, CR, TR, GU, MY, VI.
      Submission number: K022732
    • 24 Apr 2020 Z-2360-2020 Class II Terminated Packaging of infant child reduced energy electrodes was not properly sealed. Distribution: Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of NY,TX, IL, CO, TN, MI, FL, CT, GA, WA, AZ, NJ, MA, MO, NC, MD, OH, PA, CA, IA, VA, WI, MN, SC, IN, DE, KY, MT, AL, MS, NM, ME, OK, WV, SD, RI, ND, LA, AR, HI, DC, KS, NE, VT, OR, AK, NV, UT, WY, NH, PR, ID, and the countries of CA, ZA, TW, AU, JP, HK, MA, NZ, SG, BR, NL, PA, SA, AR, CL, TH, SV, CR, TR, GU, MY, VI.
      Submission number: K022732

Frequently asked questions

How many devices does PHYSIO-CONTROL, Inc. have in the registry?

The registry currently lists 2291 devices for PHYSIO-CONTROL, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list PHYSIO-CONTROL, Inc.'s devices?

Among its 50 most recently registered devices, PHYSIO-CONTROL, Inc. has devices listed in EUDAMED (50 devices).

What risk classes do PHYSIO-CONTROL, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for PHYSIO-CONTROL, Inc.'s devices are Class IIb. Each device page shows its own class and authorisation.

Are there FDA recall records for PHYSIO-CONTROL, Inc.?

FDA recall records list 72 recalls initiated by PHYSIO-CONTROL, Inc., the most recent initiated on 13 Apr 2026. 22 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for PHYSIO-CONTROL, Inc.?

EUDAMED lists 1 certificate for PHYSIO-CONTROL, Inc. (quality management system) under MDR. The most recent was issued on 30 Jul 2026.

What are the newest devices from PHYSIO-CONTROL, Inc. in the registry?

The most recently registered devices listed for PHYSIO-CONTROL, Inc. include LIFEPAK 1000 Defibrillator.

Generated automatically from registry data and not verified by a human reviewer.