Physio-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…
Read the official notice →- Date
- 2026-05-13
- Country
- United States
- Brand
- Physio-Control
- Product
- LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957,…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-03-18
USPhysio-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 →- 2025-09-10
- US
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
- 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
- 2026-05-13
- US
Katalyst Surgical, LLC recalls DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA · DeviceKatalyst Surgical, LLCWorldwide distribution - US Nationwide and the countries of Peru, Argentina,…Official notice → - US
Mint Medical GmbH recalls Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
FDA · DeviceMint Medical GmbHWorldwide distribution - US Nationwide and the countries of Germany,…Official notice → - US
BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Contamination to in-vitro diagnostic test may result in false positives.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the…Official notice → - US
Erbe Medical, LLC recalls ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus…
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported…
FDA · DeviceErbe Medical, LLCUS Nationwide distribution including in the states of IL, NY, CA, WA, UT, KY,…Official notice → - US
Spacelabs Healthcare, Inc. recalls Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A…
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of…Official notice → - US
Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
FDA · DeviceCentinel Spine, Inc.US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.Official notice →