Skip to content
RecallWatchMedical Device Safety
Class IOngoingZ-1533-2025

ZOLL Circulation, Inc. recalls Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform M…

ZOLL Circulation, Inc.San Jose, CA, United StatesReported Apr 23, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component:N/A
    79 affected lots
    11791168117811841188119711091110
    +71 more11261166116911521199120211111185119812031206120812111212117211821130112811291189118311311134119111861192117011731175118011741176118711771116116511181119119311381139114511461147114811491150115311551159116111621163116411811141110811901195112011211122112311071112111311141115113711401196

What the firm is doing

On March 4, 2025, Zoll Circulation issued a "Medical Device Product Correction Notice" to affected consignees. Zoll asked consignees to take the following actions: 1. Stop using your affected platform(s) immediately. Your patients may not receive high-quality compressions. 2.Complete the Customer Acknowledgment/ No-Charge AP NXT Platform Repair Request Form (page 3)and email it to dlam@zoll.com within 3 days. Please feel free to call me at (408) 419 - 2955 if you have any questions. 3.Return your affected platform(s) to ZOLL as soon as you receive the loaner AP NXT Platform(s) from ZOLL.

DistributionShow details

US: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong,

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class I recalls

Class IOngoingZ-2624-2026

Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System

Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a man…

  • Pulmonary Valve Prosthesis Percutaneously Delivered
  • Process control
Medtronic Heart Valves…CAJul 8, 2026
Class IOngoingZ-2622-2026

Windstone Medical Packaging, Inc. recalls A M S

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

  • General Surgery Tray
  • Material/Component Contamination
Windstone Medical Pack…MTJul 8, 2026
Class IOngoingZ-2621-2026

Windstone Medical Packaging, Inc. recalls A M S

Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

  • General Surgery Tray
  • Material/Component Contamination
Windstone Medical Pack…MTJul 8, 2026