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.
Read the official notice →- Date
- 2025-09-10
- Country
- United States
- Brand
- Physio-Control
- Product
- LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CO and MT.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-05-13
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 →- 2026-03-18
- US
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
FDA · DevicePhysio-Control, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2025-03-05
- US
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
- US
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
- US
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.
Other drugs & medical recalls in the United States
- 2025-09-10
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model…
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with…
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Due to products distributed without premarket clearance or approvals.
FDA · DeviceVisgeneer, Inc.Worldwide - U.S. Nationwide distribution in the states of CA and MI. The…Official notice → - US
Medtronic MiniMed, Inc. recalls InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose…
FDA · DeviceMedtronic MiniMed, Inc.International distribution to the countries of Argentina, Australia, Austria,…Official notice → - US
RAYSEARCH LABORATORIES AB recalls RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1,…
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL,…Official notice → - US
Reflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002…
Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
FDA · DeviceReflexion Medical, Inc.U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.Official notice →