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 deaths or serious injuries are reported, 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

2276–2300 of 5038

SevereFDA (Devices)·Z-3005-2020·2020-09-30
Siemens Syngo.via RT Image Suite Software Recall for Calibration Offset Error
Siemens is recalling Syngo.via RT Image Suite software due to a calibration offset error that could result in incorrect radiation dose or dose applied to the wrong location.
Product
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2941-2020·2020-09-30
MicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
Product
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2942-2020·2020-09-30
MicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
Product
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2975-2020·2020-09-23
Inpeco Aptio Automation Systems Recalled for Potential Sample ID Mis-association
Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.
Product
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analyti
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2965-2020·2020-09-23
Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples
Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in patient samples.
Product
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2939-2020·2020-09-16
CareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects
CareFusion is recalling BD Alaris infusion pumps because fluid ingress can cause unresponsive or stuck keys, potentially delaying or interrupting infusions.
Product
BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Category
Medical Device
Distribution
54 states
SevereFDA (Devices)·Z-2909-2020·2020-09-16
CareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect
CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because fluid ingress can cause unresponsive or stuck keypad keys, potentially delaying or interrupting medication infusions.
Product
Alaris System PC Unit Model 8015
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-2910-2020·2020-09-16
CareFusion PC Unit Front Case with Keypad Replacement Kits Recalled
CareFusion 303, Inc. is recalling PC Unit Front Case with Keypad Replacement Kits because fluid ingress may cause keys to become unresponsive or stuck, potentially delaying or interrupting life-sustaining infusions.
Product
PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-2880-2020·2020-09-02
Biosense Webster Recalls CARTO 3 System Software Due to Defect
Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.
Product
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2850-2020·2020-09-02
FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2869-2020·2020-09-02
FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2858-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2854-2020·2020-09-02
Globus Medical Recalls ALTERA Spacers with Incorrect Stainless Steel Components
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2831-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,275 kits distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2856-2020·2020-09-02
Globus Medical Recalls ALTERA Spacers Due to Incorrect Material Composition
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may be made of stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2821-2020·2020-08-26
Arjo Huntleigh Recalls Citadel Plus Bariatric Bed Frames Due to Melting Cables
Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.
Product
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2794-2020·2020-08-19
Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure
Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.
Product
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel tra
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2795-2020·2020-08-19
Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk
Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.
Product
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2734-2020·2020-08-12
Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Dose Delivery
Smiths Medical is recalling Medfusion Syringe Pump Model 4000 units due to a risk of inaccurate drug delivery following interrupted bolus or loading doses.
Product
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2716-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8000 Recall for Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.
Product
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2769-2020·2020-08-12
Beacon EUS Access System Needle Recalled Due to Cannula Detachment
Covidien is voluntarily recalling 269 Beacon EUS Access System needles because the cannula detached during procedures in three reported cases.
Product
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guide
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2758-2020·2020-08-12
Siemens Ysio Max X-Ray System Recalled for Software Defects
Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.
Product
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2750-2020·2020-08-12
GE Healthcare Recalls CARESCAPE ONE Monitors Due to Alarm Failure Risk
GE Healthcare is recalling 8,414 CARESCAPE ONE patient monitors because they may fail to provide visual and audible alarms for Ventricular Fibrillation when docked to specific host monitors.
Product
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2768-2020·2020-08-12
Beacon EUS Access System Needle Recalled Due to Cannula Detachment
Covidien is voluntarily recalling 375 units of the Beacon EUS Access System Preloaded Access 90-degree Needle because the cannula may detach during procedures.
Product
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidew
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2737-2020·2020-08-05
Hill-Rom Recalls Progressa Beds Due to Screw Tensile Strength Defect
Hill-Rom is recalling 257 Progressa Beds because screws may not meet tensile strength requirements, posing a risk of serious injury to patients or users.
Product
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Ro
Category
Medical Device
Distribution
Distributed nationwide

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2276–2300 of 5038