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

13176–13200 of 27471

HighFDA (Devices)·Z-2766-2020·2020-08-12
Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
Medline Industries Inc is recalling 1,400 endoscopic cleaning brushes because the brush may detach during use. The recall covers specific models and lots distributed nationwide.
Product
Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2743-2020·2020-08-12
Normand-Info Remisol Advance Software Recall for Erroneous Lab Results
Normand-Info is recalling Remisol Advance software version 1.12 because it deletes specific white blood cell and platelet results, potentially leading to erroneous data.
Product
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2759-2020·2020-08-12
Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
Product
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2720-2020·2020-08-12
CareFusion Alaris PCA Module 8120 Recalled for Cleaning Agent Damage
CareFusion 303, Inc. is recalling 83,532 Alaris PCA Module Model 8120 units because cleaning agents may damage connectors, causing therapy interruptions.
Product
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2755-2020·2020-08-12
Siemens Luminos dRF Max Recalled for Software Collision and Image Errors
Siemens is recalling 49 Luminos dRF Max units due to software defects that may cause system collisions or incorrect diagnostic images.
Product
SIEMENS Healthineers Luminos dRF Max Model: 10762471- 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
HighFDA (Devices)·Z-2767-2020·2020-08-12
Boss Instruments Recalls DeBakey Needle Holders Due to Plate Breakage Risk
Boss Instruments is recalling 96 DeBakey needle holders because the tungsten carbide plate can break under pressure, posing a risk to patients and medical staff.
Product
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2736-2020·2020-08-12
CareFusion Alaris Pump Module Model 8100 Recalled for Broken Platen Elements
CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because broken platen elements can cause inaccurate fluid delivery, leading to over-infusion, free-flow, or under-infusion.
Product
Alaris Pump Module Model 8100
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-2748-2020·2020-08-12
Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Risk
Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.
Product
Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2020·2020-08-12
CareFusion Alaris Pump Module 8100 Recalled for Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because cleaning agents may damage connectors, causing therapy interruptions.
Product
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2745-2020·2020-08-12
Mako Hip End Effector Recalled for Potential Bone Preparation Discrepancy
Mako Surgical Corporation is recalling 12 units of Mako Hip End Effectors due to a characterization issue that may cause discrepancies during bone preparation in certain Mako Total Hip procedures.
Product
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2719-2020·2020-08-12
CareFusion Alaris Syringe Module Recall Due to Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.
Product
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2761-2020·2020-08-12
Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
Product
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2722-2020·2020-08-12
CareFusion Alaris SpO2 Modules Recalled for Cleaning-Related Connector Damage
CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring interruptions.
Product
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2740-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8000 Infusion Pump Recall
CareFusion is recalling Alaris System PC Unit Model 8000 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
Product
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Category
Medical Device
Distribution
55 states
HighFDA (Devices)·Z-2763-2020·2020-08-12
Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect
Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.
Product
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2741-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall
CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
Product
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Category
Medical Device
Distribution
55 states
HighFDA (Devices)·Z-2754-2020·2020-08-12
BD MAX SARS-CoV-2 Reagents Recalled for Potential False Positive Results
Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.
Product
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2762-2020·2020-08-12
Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing prolonged procedures or tissue damage.
Product
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2765-2020·2020-08-12
Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect
Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
Product
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2760-2020·2020-08-12
Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect
Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.
Product
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2717-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 infusion pumps because cleaning agents may damage connectors, potentially interrupting therapy or monitoring.
Product
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2756-2020·2020-08-12
Siemens Luminos Agile Max Recalled for Software Collision and Image Errors
Siemens Medical Solutions is recalling 477 Luminos Agile Max units due to software defects that may cause system collisions or incorrect diagnostic images.
Product
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - 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
HighFDA (Devices)·Z-2735-2020·2020-08-12
Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Delivery
Smiths Medical is recalling Medfusion Syringe Pump Model 3500 units because inaccurate delivery can occur after an interrupted Bolus or Loading dose.
Product
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2757-2020·2020-08-12
Siemens Uroskop Omnia Max Recalled for Software Collision and Image Errors
Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.
Product
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - 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
HighFDA (Devices)·Z-2764-2020·2020-08-12
Boston Scientific Recalls Captiflex Snares Due to Potential Cutting Failure
Boston Scientific is recalling specific lots of Captiflex Snares because they may fail to cut polyps, potentially causing tissue damage or bleeding.
Product
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal…
Category
Medical Device
Distribution
0 states

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13176–13200 of 27471