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

20376–20400 of 27647

HighFDA (Devices)·Z-0890-2017·2016-12-28
Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise
Medtronic is recalling 230 Clearify Visualization Systems because the sterile barrier was breached, compromising product sterility. The recall covers worldwide distribution.
Product
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0795-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 76 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0809-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 20 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0778-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
AngioDynamics is recalling 4F Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches from the hub during use.
Product
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0790-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 156 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0807-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 34 units of the Adelante Breezeway 10F Straight sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0793-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 21 units of the Adelante Breezeway 8F sheath because a fragment of the inner liner detached during insertion. The product is distributed worldwide.
Product
OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0865-2017·2016-12-28
Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Electric Shock Risk
Accuray is recalling 115 CyberKnife Robotic Radiosurgery Systems (models G3, G4, VSI) due to a potential electric shock hazard during maintenance.
Product
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the…
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0776-2017·2016-12-28
AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 145 boxes of Stiffened Micro-Introducer Kits because the sheath/dilator components may have a rotating luer that detaches during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2017·2016-12-28
Amendia Recalls Optimus Fixed Awl Due to Tip Breakage During Surgery
Amendia, Inc. is recalling nine Optimus Fixed Awl devices because the tip broke after impaction during surgery. The devices were distributed to Florida, Georgia, Illinois, Missouri, and Texas.
Product
Optimus Fixed Awl
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0898-2017·2016-12-28
Teleflex Recalls Mucosal Atomization Devices Due to Incomplete Atomization
Teleflex Medical is recalling Mucosal Atomization Devices because they may produce a straight stream instead of a fully atomized plume of medication.
Product
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0806-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 16 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0811-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Fragmentation
Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0899-2017·2016-12-28
Radiometer AQURE System Software Recalled for Patient View Display Error
Radiometer America Inc is recalling AQURE System software due to a design error that may cause users to misread patient parameters and values.
Product
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0797-2017·2016-12-28
Oscor Medical Device Recall for Sheath Liner Fragmentation
Oscor, Inc. is recalling 11 Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0803-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 74 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The device is used to introduce catheters to heart chambers.
Product
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0784-2017·2016-12-28
Ultroid Procedure Pack Recalled for Quality System Non-Compliance
Ultroid Technologies is recalling 52,084 procedure packs because they were not manufactured under required quality system controls.
Product
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0877-2017·2016-12-28
BD SurePath Collection Vials Recalled Due to Cracked Caps
Becton Dickinson is recalling SurePath collection vials because cracked caps may allow preservative fluid to leak.
Product
BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0774-2017·2016-12-28
AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 751 Stiffened Micro-Introducer Kits because a component may detach during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0794-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 991 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0799-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 21 units of the Adelante Breezway 8F Straight sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0870-2017·2016-12-28
Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Product
8470-009-030 3.0MM Precision Round, 16CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0781-2017·2016-12-28
Nuvectra Recalls Algovita Spinal Cord Stimulation Leads Due to Stylet Protrusion
Nuvectra is recalling Algovita Spinal Cord Stimulation System percutaneous leads because the stylet may protrude beyond the distal lead tip.
Product
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2017·2016-12-28
Amendia Recalls Black Widow Spinal Plates Due to Mating Feature Defect
Amendia, Inc. is recalling 48 units of Black Widow Buttress Plates due to a design defect in the mating feature between the plate and screw.
Product
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0813-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation
Oscor, Inc. is recalling 215 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states

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20376–20400 of 27647