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

20426–20450 of 27682

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
HighFDA (Devices)·Z-0812-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation
Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because an inner liner fragment was found during insertion. The recall covers 1,729 units distributed worldwide.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 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-0745-2017·2016-12-21
BD Vacutainer Push Button Blood Collection Set Recall for Barrel Separation
Becton Dickinson is recalling specific lots of BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the safety feature is activated.
Product
BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0760-2017·2016-12-21
Inovo Purefill Oxygen Compressor Recalled for Operational Failure Risk
Inovo, Inc. is recalling 117 Inovo Purefill Oxygen Compressor Model PF1100 units because the device can fail during operation.
Product
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0746-2017·2016-12-21
Steris Recalls Harmony Insight Diagnostic Monitor Support Systems
Steris Corporation is recalling 63 Harmony Insight Diagnostic Monitor Support Systems because spring arm screws may not be properly secured and could become loose.
Product
Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0765-2017·2016-12-21
Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage
Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or during use.
Product
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2017·2016-12-21
Integra York Metzenbaum Scissors Recalled Due to Packaging Seal Separation
Integra York PA, Inc. is recalling 50 units of sterile Metzenbaum Scissors because packaging seals may separate, compromising sterility.
Product
Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0751-2017·2016-12-21
Integra York Recalls Sterile Rochester-Pean Hemostatic Forceps Due to Seal Defect
Integra York PA, Inc. is recalling 150 units of sterile Rochester-Pean Hemostatic Forceps because packaging seals may separate, compromising sterility.
Product
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0761-2017·2016-12-21
Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss
Physio-Control is recalling 1,399 LIFEPAK 15 monitor/defibrillators because they may power down unexpectedly during use.
Product
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0759-2017·2016-12-21
Telefac Medical Recalls Weck Facial Closure Systems Due to Detachment Risk
Teleflex Medical is recalling 2,265 units of Weck Facial Closure Systems because the device wings may partially detach from the shield during use.
Product
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0764-2017·2016-12-21
Teleflex Visistat Skin Staplers Recalled for Sterility Deficiency
Teleflex Medical is recalling Visistat 35W disposable skin staplers because improper packaging seals mean sterility is not assured.
Product
WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2017·2016-12-21
Prism Medical Carry Bar Recall Due to Breaking Plastic Component
Prism Medical is recalling carry bars for patient lifts because a black plastic puck may break, posing a risk of harm to patients.
Product
Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2017·2016-12-21
Encore Medical Recalls Empowr PS Knee System Box Cut Guides
Encore Medical is recalling 162 Empowr PS Knee System Box Cut Guides because femoral chipping occurred during surgery.
Product
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0731-2017·2016-12-21
Elekta Recalls MOSAIQ Oncology Information System Due to Data Saving Error
Elekta is recalling 47 MOSAIQ Oncology Information System units because edits to particle field definition parameters may not be saved.
Product
MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
Category
Medical Device
Distribution
Distributed nationwide

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20426–20450 of 27682