Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

23901–23925 of 27663

SevereFDA (Devices)·Z-0868-2015·2014-12-31
Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0585-2015·2014-12-31
Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult Radiotranslucent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
Product
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0867-2015·2014-12-31
Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach during use, potentially compromising airway management.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0587-2015·2014-12-31
Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper device operation.
Product
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0584-2015·2014-12-31
Heart Sync Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult/Child Radiotransparent Electrodes because they do not connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
Product
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0865-2015·2014-12-31
Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment Risk
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0872-2015·2014-12-31
Invacare PerfectO2 Oxygen Concentrator Capacitor Recall for Fire Hazard
Invacare is recalling Dianz Capacitors used in PerfectO2 Oxygen Concentrators because they may rupture and cause a fire.
Product
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0869-2015·2014-12-31
Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk
Halyard Health is recalling KimVent Microcuff Subglottic Suctioning Endotracheal Tubes because the cuff inflation line may detach during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0866-2015·2014-12-31
Halyard KimVent Endotracheal Tubes Recalled for Cuff Line Detachment
Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach from the tube during use.
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0583-2015·2014-12-31
Heart Sync Electrodes Recalled for Incompatibility with Philips AEDs
Heart Sync, Inc. is recalling Adult Radiotransparent Electrodes that fail to connect with Philips FR3 or FRx AED units, potentially preventing defibrillation.
Product
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0848-2015·2014-12-31
Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides Due to Biased Results
Ortho-Clinical Diagnostics is recalling specific VITROS TRIG slides due to a potential for biased test results. The recall affects 380 units in the US and 155 units internationally.
Product
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0586-2015·2014-12-31
Heart Sync Multi-function Defibrillation Electrodes Recalled for Incompatibility
Heart Sync, Inc. is recalling multi-function defibrillation electrodes that do not connect with Philips FR3 or FRx AED units, potentially preventing proper use.
Product
ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0802-2015·2014-12-31
GE Healthcare Pediatric Defibrillation Electrodes Recalled for Arcing Risk
Leonhard Lang GmbH is recalling GE Healthcare Pediatric Defibrillation Electrodes because arcing may cause malfunction, delaying or preventing life-saving therapy.
Product
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0859-2015·2014-12-31
Siemens ADVIA Centaur Laboratory Analyzer Recall for Tubing Crack Risk
Siemens is recalling ADVIA Centaur laboratory analyzers because a slight crack in the tubing at the reservoir connector may occur due to mechanical stress.
Product
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0857-2015·2014-12-31
Iris Diagnostics Recalls RTH8 Rotor for StatSpin Express 4 Centrifuge
Iris Diagnostics is recalling RTH8 rotors for the StatSpin Express 4 Horizontal Centrifuge because the parts may develop cracks with use over time.
Product
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2015·2014-12-31
Horiba Lite DM Software Recall for Potential Data Mismatch
Horiba Instruments is recalling Lite DM software versions 2.0.0.19 and lower due to a bug that may apply test results to the wrong patient order.
Product
Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0863-2015·2014-12-31
Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly
Bausch & Lomb is recalling 79 Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.
Product
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and…
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0837-2015·2014-12-31
Mindray Recalls IBP Modules for DPM 6 and DPM 7 Patient Monitors
Mindray is recalling IBP modules for DPM 6 and DPM 7 patient monitors because blood pressure data may display in the wrong screen tile.
Product
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple…
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0874-2015·2014-12-31
Ebi Solitaire-C Cervical Spacer Drill Sleeves Recalled for Design Deficiency
Ebi, LLC is recalling 193 units of Solitaire-C Cervical Spacer System drill sleeves because a design defect allows instruments to penetrate 1.0 mm beyond intended depths.
Product
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0836-2015·2014-12-31
Ion Beam Applications Recalls adaPT insight Software Due to Calibration Error
Ion Beam Applications S.A. is recalling one unit of adaPT insight software in Pennsylvania due to a calibration file error and a gantry collision incident.
Product
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0853-2015·2014-12-31
Zimmer Recalls Persona Cemented Tibial Broach Inserter/Extractor Handles
Zimmer, Inc. is recalling 83 units of Persona Cemented Tibial Broach Inserter/Extractor Handles because the magnet cover may disassociate and be lost during surgery.
Product
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0873-2015·2014-12-31
Radiometer HemoCue Glucose 201 Microcuvettes Recalled for Discoloration and Inaccurate Results
Radiometer America Inc. is recalling HemoCue Glucose 201 Microcuvettes because they show discoloration and provide results outside specification near the end of their shelf life.
Product
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0862-2015·2014-12-31
Bausch & Lomb Stellaris PC Laser Recall for Software Anomaly
Bausch & Lomb is recalling 106 Stellaris PC laser systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.
Product
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0832-2015·2014-12-31
Instrumentation Laboratory Recalls HemosIL PT-Fibrinogen HS PLUS Reagent
Instrumentation Laboratory is recalling HemosIL PT-Fibrinogen HS PLUS reagent kits because some vials exhibit discoloration that causes prolonged prothrombin clotting times.
Product
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0864-2015·2014-12-31
Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly
Bausch & Lomb is recalling two Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.
Product
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and…
Category
Medical Device
Distribution
21 states

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23901–23925 of 27663