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

19201–19225 of 40248

HighFDA (Devices)·Z-0220-2020·2019-11-06
LivaNova Recalls SORIN Heater-Cooler Systems Due to Disinfectant Failure
LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.
Product
SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: "…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0252-2020·2019-11-06
BD Vacutainer Eclipse Blood Collection Needles Recalled for Missing Bevel
Becton Dickinson is recalling specific lots of BD Vacutainer Eclipse Blood Collection Needles because a missing bevel on the non-patient end caused blood leakage.
Product
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0251-2020·2019-11-06
Eversense CGM Sensors Recalled for Premature Function Failure
Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.
Product
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0239-2020·2019-11-06
Medtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates
Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Product
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0229-2020·2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
Product
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0242-2020·2019-11-06
Alto Development Recalls Thorecon Plating System Kits Due to Molding Defect
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Product
A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0235-2020·2019-11-06
Mindray Accutorr 3 Vital Signs Monitor Recalled for Software Features
Mindray is recalling 13 Accutorr 3 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Product
Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0232-2020·2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling 305 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.
Product
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0223-2020·2019-11-06
Synthes Spinal Screws Recalled Due to Incorrect Diameter
Synthes (USA) Products LLC is recalling six 3.5mm spinal screws that measure 4.0mm in diameter. The product was distributed to New Jersey.
Product
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0244-2020·2019-11-06
Alto Development Recalls Thorecon Plating System Kits Due to Molding Defect
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Product
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0260-2020·2019-11-06
Dario Blood Glucose Monitoring System App Recall for Duplicate Logging
Labstyle Innovations is recalling the Dario Blood Glucose Monitoring System Android app versions 4.3.0-4.3.2 because it may duplicate blood glucose readings.
Product
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0228-2020·2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling 107 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
Product
Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0256-2020·2019-11-06
Centurion Medical Recalls Port Access Infusion Kits with 1-Inch Needles
Centurion Medical Products Corporation is recalling 200 Port Access Infusion Kits with 1-inch needles distributed in Illinois due to a supplier-initiated recall.
Product
PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0245-2020·2019-11-06
A&E Medical Thorecon Plating System Kits Recalled for Molding Defect
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the tensioners inoperable.
Product
A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0261-2020·2019-11-06
Implant Direct Scan Adapter Assembly Recalled for Incorrect Assembly
Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.
Product
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0241-2020·2019-11-06
Medtronic CareLink SmartSync Device Manager Recall for Inaccurate Longevity Estimates
Medtronic is recalling CareLink SmartSync Device Manager units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Product
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0262-2020·2019-11-06
POM Medical Recalls Procedural Oxygen Masks Due to Defective Re-breather Bags
POM Medical LLC is recalling 5,610 procedural oxygen masks because the re-breather bag may not inflate or the oxygen line may pop off due to a clogged port.
Product
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0238-2020·2019-11-06
Mindray Rosebud Vital Signs Monitor Recalled for Unapproved Software Features
Mindray is recalling 9 Rosebud Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Product
Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0254-2020·2019-11-06
Centurion Medical Products Recalls GRIPPER Needles in Illinois
Centurion Medical Products Corporation is recalling GRIPPER Needles in Illinois. The recall was initiated by the supplier.
Product
Maintenance Flush Kit/Blood Draw Product Code: DT19335
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0246-2020·2019-11-06
FDA Recalls Thorecon Plating System Kits Due to Molding Defect
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Product
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0240-2020·2019-11-06
Medtronic CareLink Encore Programmer Recall for Inaccurate Longevity Estimates
Medtronic is recalling 6,713 CareLink Encore Programmer units worldwide because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Product
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0224-2020·2019-11-06
Hycor Biomedical Recalls Leaking HYTEC Stop Solution Bottles
Hycor Biomedical is recalling HYTEC Stop Solution bottles that may leak a caustic sodium hydroxide solution. The product is used in specific allergy testing kits.
Product
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0248-2020·2019-11-06
Caire SAROS Oxygen System Model 3000 Recalled for Power Issue
Caire, Inc. is recalling 10 SAROS Oxygen System Model 3000 units due to an electronics control issue that prevents the device from powering on with battery power only.
Product
SAROS Oxygen System Model 3000
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0226-2020·2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.
Product
Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0237-2020·2019-11-06
Mindray Rosie4 Vital Signs Monitor Recalled for Software Clearance Issues
Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Product
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP).…
Category
Medical Device
Distribution
Distributed nationwide

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19201–19225 of 40248