The Recall Desk

Hazard

Delayed Detection recalls

14 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
14
Critical
0
Severe
7
Most recent
2025-04-02

Of the 14 delayed detection recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (50%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all delayed detection recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–14 of 14

  • HighFDA (Devices)·Z-1454-2025·2025-04-02

    Helix Elite Quality Control Material Recalled for Delayed Detection and QC Failure

    Microbiologics Inc is recalling its Helix Elite RSV quality control material (Lot HE0044-131) because the RSV component may produce delayed test results and could fail quality control checks. This Class II recall affects 28 units distributed worldwide.

    Product
    Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2024·2024-01-24

    CareEvent Medical Device Push Notifications May Fail to Send

    The CareEvent patient monitoring device may fail to send push notifications, potentially delaying detection of patient condition changes.

    Product
    (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2024·2023-10-18

    Infusion pump component force sensor may malfunction or trigger false alarms

    Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.

    Product
    Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2024·2023-10-18

    Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift

    The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.

    Product
    Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2024·2023-10-18

    Syringe Pump Force Sensor Drift May Cause Detection Delays or False Alarms

    Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.

    Product
    Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2024·2023-10-18

    Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall

    Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.

    Product
    Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2024·2023-10-18

    Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms

    Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.

    Product
    Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1159-2020·2020-02-19

    Pacific Medical Group Recalls Button-Style Tocotransducers Due to Unverified Components

    Pacific Medical Group is recalling 9,679 Button-Style Tocotransducers serviced with non-OEM components that were not appropriately verified, posing risks of inaccurate monitoring and burns.

    Product
    Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1168-2020·2020-02-19

    Pacific Medical Toco MP Transducers Recalled for Non-OEM Components

    Pacific Medical Group Inc. is recalling Toco MP Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal monitoring and patient burns.

    Product
    Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1164-2020·2020-02-19

    Pacific Medical Ultrasound Transducers Recalled for Unverified Service Components

    Pacific Medical Group is recalling 1,994 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate fetal and maternal monitoring.

    Product
    Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1166-2020·2020-02-19

    Pacific Medical Toco+ Transducers Recalled for Unverified Service Components

    Pacific Medical Group is recalling 2,170 Toco+ transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal/maternal monitoring and patient burns.

    Product
    Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1161-2020·2020-02-19

    Pacific Medical Group Recalls Ultrasound Transducers Serviced with Non-OEM Parts

    Pacific Medical Group is recalling 6,481 Button-Style Ultrasound Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal and maternal monitoring or patient burns.

    Product
    Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Cor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1167-2020·2020-02-19

    Pacific Medical Ultrasound Transducers Recalled for Non-OEM Component Use

    Pacific Medical Group is recalling 5,897 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate monitoring or patient burns.

    Product
    Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1162-2020·2020-02-19

    Pacific Medical Group Recalls Ultrasound Transducers Serviced with Non-OEM Parts

    Pacific Medical Group is recalling Loop-Style Ultrasound Transducers serviced with unverified non-OEM components. The parts may cause inaccurate fetal monitoring and patient burns.

    Product
    Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corom
    Category
    Medical Device
    Distribution
    Distributed nationwide