Hazard

Mis Configuration recalls

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

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2025-05-07

Of the 9 mis configuration recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 mis configuration 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.

1–9 of 9

ModerateFDA (Devices)·Z-1686-2025·2025-05-07
IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.
Product
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2736-2024·2024-09-04
Lab analyzer incorrectly configured for complex testing at waived facilities
Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.
Product
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2021·2020-12-23
Terumo Capiox FX25 Advance Oxygenator Recall for Configuration Error
Terumo is recalling Capiox FX25 Advance Oxygenators because they may have the incorrect East or West configuration. The recall affects 5,079 units distributed in the US and abroad.
Product
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0293-2017·2016-10-26
Philips IntelliVue MX40 Patient Monitor Recalled for ECG Alarm Configuration Issue
Philips is recalling 2,212 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms. Users should contact Philips for a software update.
Product
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 4535646153
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0292-2017·2016-10-26
Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue
Philips is recalling 1,824 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms.
Product
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 4535
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0187-2014·2013-11-20
St. Jude Medical Recalls Safire Duo Ablation Catheters Due to Connector Error
St. Jude Medical is voluntarily recalling 46 Safire Duo Ablation Catheters because they have a cable connector configuration that differs from the intended design.
Product
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2111-2013·2013-09-04
Becton Dickinson PrepStain Tecan US-I Recall for Incorrect Rack Settings
Becton Dickinson is recalling 890 PrepStain Tecan US-I instruments because a rack setting was incorrectly entered during routine maintenance.
Product
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2110-2013·2013-09-04
Becton Dickinson PrepStain AG System Recall for Incorrect Rack Setting
Becton Dickinson is recalling 890 PrepStain AG systems because a rack setting was incorrectly entered during routine maintenance.
Product
PrepStain AG. For use in the screening and detection of cervical cancer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0071-2013·2012-10-24
Terumo Backplate Replacement CXFVR 1500 Holder Recalled for Incorrect Configuration
Terumo is recalling 33 Backplate Replacement CXFVR 1500 Holders because they were manufactured with an incorrect configuration of connector supports.
Product
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines tha
Category
Medical Device
Distribution
Distributed nationwide