Physio-Control, Inc.: 43 FDA recall reports
Every medical device recall the FDA has published for Physio-Control, Inc.. The fault, and how the agency graded it.
43Reports
7Class I
22Ongoing
2026-05-13Most recent
7 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001
Z-2065-2026 · Class II · reported 2026-05-13 · Ongoing
- Why it was recalled
- 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.
- Product
- LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122
- Where it went
- 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.
- How much
- 206
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI cod
Z-1544-2026 · Class II · reported 2026-03-18 · Ongoing
- Why it was recalled
- Due to pediatric defibrillator electrode delamination
- Product
- PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).
- Where it went
- 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.
- How much
- 16,499 electrodes (US/OUS: 8327/8172)
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The
Z-2499-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Due to required inspections not being performed on products/units that have gone through servicing.
- Product
- LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.
- Where it went
- U.S. Nationwide distribution in the states of CO and MT.
- How much
- 1 unit
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 /
Z-2497-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Due to required inspections not being performed on products/units that have gone through servicing.
- Product
- LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
- Where it went
- U.S. Nationwide distribution in the states of CO and MT.
- How much
- 4 units
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 /
Z-2498-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Due to required inspections not being performed on products/units that have gone through servicing.
- Product
- LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.
- Where it went
- U.S. Nationwide distribution in the states of CO and MT.
- How much
- 3 units
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Z-1232-2025 · Class II · reported 2025-03-05 · Ongoing
- Why it was recalled
- Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- Product
- LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
- Where it went
- U.S.: WV O.U.S.: N/A
- How much
- 1
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Senso
Z-1184-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
- Product
- LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8¿ SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO¿), and methemoglobin saturation (SpMet¿) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
- Where it went
- 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.
- How much
- 622
LIFEPAK 35 ECG cable REF 11111-000041
Z-1102-2025 · Class II · reported 2025-02-12 · Ongoing
- Why it was recalled
- Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
- Product
- LIFEPAK 35 ECG cable REF 11111-000041
- Where it went
- 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.
- How much
- 245 units
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99
Z-0230-2025 · Class II · reported 2024-11-06 · Ongoing
- Why it was recalled
- Due to an out of tolerance tool being used on monitor/defibrillator systems.
- Product
- LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
- Where it went
- U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
- How much
- 105 systems
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15
Z-0142-2025 · Class II · reported 2024-10-30 · Ongoing
- Why it was recalled
- 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.
- Product
- STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
- Where it went
- 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.
- How much
- 3,617 devices (US-3315 and O.U.S - 302 devices)
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Z-0567-2024 · Class II · reported 2023-12-27 · Ongoing
- Why it was recalled
- 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.
- Product
- AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
- Where it went
- 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.
- How much
- 18,732
LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Z-0296-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 1 unit
LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Z-0298-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 1 unit
LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
Z-0303-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 8 units
LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Z-0305-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 2 units
LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Z-0300-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 1 unit
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Z-0302-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 1 units
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Z-0299-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 5 units
LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
Z-0297-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 8 yrs.
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Z-0304-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 1 unit
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Z-0301-2024 · Class II · reported 2023-11-22 · Ongoing
- Why it was recalled
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Product
- LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
- Where it went
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- How much
- 4 units
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Z-0745-2022 · Class III · reported 2022-03-16 · Terminated
- Why it was recalled
- Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
- Product
- HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
- Where it went
- U.S.: AK
- How much
- 1
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor
Z-1189-2021 · Class II · reported 2021-03-17 · Ongoing
- Why it was recalled
- Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
- Product
- PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.
- Where it went
- 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.
- How much
- 89,763 units
Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation El
Z-2360-2020 · Class II · reported 2020-06-17 · Terminated
- Why it was recalled
- Packaging of infant child reduced energy electrodes was not properly sealed.
- Product
- Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.
- Where it went
- 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.
- How much
- 6732
Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 def
Z-2359-2020 · Class II · reported 2020-06-17 · Terminated
- Why it was recalled
- Packaging of infant child reduced energy electrodes was not properly sealed.
- Product
- Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.
- Where it went
- 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.
- How much
- 118689
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790
Z-1633-2020 · Class II · reported 2020-04-08 · Terminated
- Why it was recalled
- Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment
- Product
- LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.
- Where it went
- Worldwide distribution - US Nationwide distribution and countries of Afghanistan, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Congo, Cook Islands, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Macedonia, the former Yugoslav Republic of, Madagascar, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Province of...
- How much
- 173,459 units
LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained a
Z-0816-2020 · Class II · reported 2020-01-22 · Terminated
- Why it was recalled
- Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
- Product
- LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
- Where it went
- Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, Costa Rica, Canada, Singapore, Australia, France, Croatia, Italy , Sweden, Hungary,United Arab Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republic of the, Nigeria, Lao People's Democratic Republic, Russian Federation, Cyprus, Pakistan, Faroe Islands, Gabon,Libya, Thailand, Indonesia, Lithuania, Georgia, Malta, Macedonia, the former Yugoslav...
- How much
- 29952
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Z-0817-2020 · Class II · reported 2020-01-22 · Terminated
- Why it was recalled
- Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
- Product
- LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
- Where it went
- Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, Costa Rica, Canada, Singapore, Australia, France, Croatia, Italy , Sweden, Hungary,United Arab Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republic of the, Nigeria, Lao People's Democratic Republic, Russian Federation, Cyprus, Pakistan, Faroe Islands, Gabon,Libya, Thailand, Indonesia, Lithuania, Georgia, Malta, Macedonia, the former Yugoslav...
- How much
- 705
Class I
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a comple
Z-0862-2019 · Class I · reported 2019-03-06 · Terminated
- Why it was recalled
- Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
- Product
- LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
- Where it went
- Worldwide Distribution
- How much
- 13,005 units
Class I
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15
Z-0863-2019 · Class I · reported 2019-03-06 · Terminated
- Why it was recalled
- Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
- Product
- LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
- Where it went
- Worldwide Distribution
- How much
- 682 kits
Showing the 30 most recent of 43. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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