Hazard

Occlusion Detection Failure recalls

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

What the numbers show

Total: 19
Critical: 0
Severe: 7
Most recent: 2024-08-14

Of the 19 occlusion detection failure 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 (37%) 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 occlusion detection failure 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.

1–19 of 19

SevereFDA (Devices)·Z-2419-2024·2024-08-14
CADD-Solis Ambulatory Infusion Pumps with Software Defects Affecting Device Responsiveness
CADD-Solis Model 2100 infusion pumps with pre-v4.3 software have defects affecting occlusion detection and device responsiveness. Manufacturer recommends updating to software version 4.3 (2023) to resolve the issues.
Product
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that re
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0530-2022·2022-02-09
Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures
Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1666-2018·2018-05-16
Baxter Infusion Pump Recalled for Improper Testing Documentation
Baxter Healthcare Corporation is recalling 444 Sigma Spectrum Infusion Pumps because service technicians omitted required release tests, which could lead to serious adverse health consequences.
Product
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical dru
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2141-2016·2016-07-20
Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure
Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.
Product
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2139-2016·2016-07-20
Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure
Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.
Product
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncol
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2142-2016·2016-07-20
Hospira LifeCare Pump Model 4200 PCA Infuser Recalled for Occlusion Detection Failure
Hospira is recalling 6,268 LifeCare Pump Model 4200 PCA Infusers because they may fail to detect distal occlusions, a defect that caused one serious injury.
Product
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2140-2016·2016-07-20
Hospira PCA 3 Infusion Pump Recall for Occlusion Detection Failure
Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.
Product
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 inf
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2014·2013-11-27
Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift
Hospira is recalling GemStar infusion pumps because pressure sensor calibration drift may cause the device to fail occlusion tests or report false errors.
Product
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0350-2014·2013-11-27
Hospira Recalls GemStar Infusion Pumps Due to Pressure Sensor Calibration Drift
Hospira is recalling 43,840 GemStar infusion pumps worldwide because pressure sensor calibration drift may cause the device to fail occlusion tests or issue false alarms.
Product
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0286-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Pressure Sensor Pin
Hospira is recalling 214 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0284-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Pressure Sensor Pin
Hospira is recalling 10,669 Plum A+ Infusion Systems because the distal pressure sensor pin may break. This defect can prevent the device from detecting occlusions in the administration set.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0285-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 71 Plum A+ Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0289-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 21,551 Plum A+3 Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0290-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira Inc. is recalling Plum A+ Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0207-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift
Hospira is recalling 182,970 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or missed occlusions.
Product
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0288-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 7,692 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0283-2014·2013-11-20
Hospira Recalls Plum A+ Infusers Due to Broken Pressure Sensor Pin
Hospira Inc. is recalling 179 Plum A+ Hyperbaric Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0208-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift
Hospira is recalling 7,691 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or undetected occlusions.
Product
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira Inc. is recalling 182,971 Plum A+ Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Medical Device
Distribution
Distributed nationwide