Data Foundry

Medical device recalls 2025

Brand Name: AutoPulse NXT Resuscitation System Product Name:… — Class I medical device recall Z-1533-2025

Ongoing recall by ZOLL Circulation, Inc., reported 2025-04-23, distributed in AL, CA, CT, FL, IL, KS, LA, MN…. AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to

Recall numberZ-1533-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmZOLL Circulation, Inc., San Jose, CA, United States
Recall initiated2025-03-04
Classified2025-04-11
Reported by FDA2025-04-23
DistributedAL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK, PA, TX, WI
Countries outside the USCA, HK
Quantity91
UPC / GTIN / UDI-DI00849111003384
Serial numbers1107, 1108, 1109, 1110, 1111, 1112, 1113, 1114, 1115, 1116, 1118, 1119, 1120, 1121, 1122, 1123, 1126, 1128, 1129, 1130, 1131, 1134, 1137, 1138, 1139 and 54 more
Model numbers200, 8700-001070-1

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1533-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.