Browse Device Recalls
38 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 38 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 21, 2026 | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog ... | Due to pediatric defibrillator electrode delamination | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-0000... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-00195... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Feb 3, 2025 | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients i... | Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | Class II | Physio-Control, Inc. |
| Jan 21, 2025 | LIFEPAK 35 ECG cable REF 11111-000041 | Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions | Class II | Physio-Control, Inc. |
| Jan 21, 2025 | LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2... | Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methe... | Class II | Physio-Control, Inc. |
| Aug 30, 2024 | LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 9... | Due to an out of tolerance tool being used on monitor/defibrillator systems. | Class II | Physio-Control, Inc. |
| Aug 9, 2024 | STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL ... | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as ... | Class II | Physio-Control, Inc. |
| Nov 6, 2023 | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 1114... | AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the ... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Jan 13, 2022 | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad... | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | Class III | Physio-Control, Inc. |
| Jan 14, 2021 | PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 def... | Due to complaints received regarding missing lid magnets which may result in premature battery de... | Class II | Physio-Control, Inc. |
| Apr 24, 2020 | Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-0... | Packaging of infant child reduced energy electrodes was not properly sealed. | Class II | Physio-Control, Inc. |
| Apr 24, 2020 | Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child... | Packaging of infant child reduced energy electrodes was not properly sealed. | Class II | Physio-Control, Inc. |
| Mar 20, 2020 | LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U30... | Automated External Defibrillators may not detect a patient connection due to mechanical wear-thr... | Class II | Physio-Control, Inc. |
| Dec 20, 2019 | LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or receive... | Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed a... | Class II | Physio-Control, Inc. |
| Dec 20, 2019 | LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits | Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed a... | Class II | Physio-Control, Inc. |
| Dec 4, 2017 | LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e... | Physio-Control is aware that some devices have had power-related failures as customers prepared t... | Class I | Physio-Control, Inc. |
| Oct 27, 2017 | LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-00... | The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing... | Class I | Physio-Control, Inc. |
| Oct 27, 2017 | LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 ... | The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing... | Class I | Physio-Control, Inc. |
| Jan 16, 2017 | LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended f... | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during... | Class II | Physio-Control, Inc. |
| Jan 16, 2017 | LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is... | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during... | Class II | Physio-Control, Inc. |
| Jan 13, 2017 | The LIFEPAK 1000 defibrillator is intended for use by personnel who are autho... | The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off... | Class I | Physio-Control, Inc. |
| Jan 12, 2017 | LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monit... | The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer b... | Class I | Physio-Control, Inc. |
| May 25, 2016 | LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s... | LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initia... | Class II | Physio-Control, Inc. |
| Jan 27, 2016 | LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed.... | The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the ... | Class II | Physio-Control, Inc. |
| May 9, 2014 | LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP100... | Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK... | Class II | Physio-Control, Inc. |
| Mar 11, 2010 | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical ... | Customer complaint was received relating to a LifePak15 device that would power on then power dow... | Class II | Physio-Control, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.