Physio-Control, Inc. recalls PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog…
Due to pediatric defibrillator electrode delamination
Read the official notice →- Date
- 2026-03-18
- Country
- United States
- Brand
- Physio-Control
- Product
- PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Physio-Control recalls
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USPhysio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957,…
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…
FDA · DevicePhysio-Control, Inc.US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA,…Official notice →- 2025-09-10
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Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is…
Due to required inspections not being performed on products/units that have gone through servicing.
FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution in the states of CO and MT.Official notice → - 2025-03-05
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Physio-Control, Inc. recalls LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
- 2025-02-26
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Physio-Control, Inc. recalls LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿…
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA,…Official notice → - 2025-02-12
- US
Physio-Control, Inc. recalls LIFEPAK 35 ECG cable REF 11111-000041
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
FDA · DevicePhysio-Control, Inc.U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI,…Official notice → - 2024-11-06
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Physio-Control, Inc. recalls 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…
Due to an out of tolerance tool being used on monitor/defibrillator systems.
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Medartis AG recalls Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable.…
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
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Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the…
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Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
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