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

19551–19575 of 27682

SevereFDA (Devices)·Z-2291-2017·2017-06-14
Arrow PICC Recall Initiated Due to Safety Cover Disengagement and Needlestick Injury
Arrow International is recalling Arrow PICC products with Chlorag+ard Technology due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2297-2017·2017-06-14
Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2264-2017·2017-06-14
Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling 43,394 central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2282-2017·2017-06-14
Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2284-2017·2017-06-14
Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2288-2017·2017-06-14
Arrow Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2254-2017·2017-06-14
Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling specific central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2296-2017·2017-06-14
Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2226-2017·2017-06-14
Magellan LeadCare Blood Test Kits Underestimate Lead Concentrations
Magellan Diagnostics is recalling LeadCare Ultra and Plus test kits because they may underestimate lead levels in venous blood samples.
Product
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2302-2017·2017-06-14
Arrow Arterial Line Kits Recalled for Needlestick Injury Risk
Arrow International is recalling Arterial Line Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2290-2017·2017-06-14
Arrow International Recalls Access Kits Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2269-2017·2017-06-14
Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits nationwide due to reports of safety cover disengagement and needlestick injuries.
Product
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2260-2017·2017-06-14
Arrow International Recalls Hemodialysis Catheter Kits Due to Needlestick Risk
Arrow International is recalling 43,394 hemodialysis catheterization kits nationwide because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2256-2017·2017-06-14
Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk
Arrow International is recalling Pressure Injectable PICC Kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2301-2017·2017-06-14
Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk
Arrow International is recalling QuickFlash Radial Artery Catheterization Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2270-2017·2017-06-14
Arrow International Recalls CVC Kits Due to Needlestick Injury Risk
Arrow International is recalling ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2276-2017·2017-06-14
Arrow Catheter Kits Recalled for Needlestick Injury Risk
Arrow International is recalling catheterization kits because the packaged BD Eclipse Needle has a safety cover that can disengage, causing needlestick injuries.
Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2233-2017·2017-06-14
ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Oxygen Masks. The recall was initiated due to quality concerns, though no specific defect is described in the source.
Product
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2234-2017·2017-06-14
ConvaTec Recalls Non-Rebreather Masks Due to Potential Valve Defect
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Masks due to a potential defect in the check valve. The recall covers units distributed in the US and internationally.
Product
Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2308-2017·2017-06-14
Arrow International Recalls Hemodialysis Catheterization Kits
Arrow International Inc. is recalling ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kits due to a Class II recall.
Product
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2228-2017·2017-06-14
ConvaTec Recalls Elongated Oxygen Masks Due to Tubing Detachment Risk
ConvaTec is recalling elongated oxygen masks because tubing may detach from the connector, potentially disrupting oxygen supply to users.
Product
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2317-2017·2017-06-14
DePuy Synthes Orthopedic Instruments Recalled for Quality System Violations
DePuy Orthopaedics is recalling 345 orthopedic instruments modified by U.S. distributors because they were made outside quality system regulations, potentially compromising safety and effectiveness.
Product
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2271-2017·2017-06-14
Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk
Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2017·2017-06-14
ConvaTec Recalls Elongated Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling elongated oxygen masks in the US and 27 other countries. The recall was initiated by the firm and is classified as FDA Class II.
Product
Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2318-2017·2017-06-14
Zimmer Biomet Recalls Vitality Spinal Fixation System Drivers
Zimmer Biomet is recalling Vitality T27 Final Drivers and Torque Limiting Handles because they may create torsional springs that damage the device or cause torque values to go out of specification.
Product
Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
Category
Medical Device
Distribution
Distributed nationwide

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19551–19575 of 27682