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

19526–19550 of 27682

SevereFDA (Devices)·Z-2172-2017·2017-06-14
Laserex Systems Recalls Ellex Tango Reflex Laser Ophthalmic Units
Laserex Systems Inc. is recalling 83 Ellex Tango Reflex laser ophthalmic units because they may emit laser energy without the fire button being pressed.
Product
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2265-2017·2017-06-14
Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk
Arrow International is recalling 43,394 units of ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits nationwide due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.
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
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2259-2017·2017-06-14
Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling 43,394 units of MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2281-2017·2017-06-14
Arrow VPS Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow(R) VPS(R) Access Kit for use with 4 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 which…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2268-2017·2017-06-14
Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits due to safety cover disengagement and needlestick injury reports.
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-2248-2017·2017-06-14
Stryker Recalls Berchtold Chromophare F300 Exam Lights Due to Mounting Defect
Stryker Communications is recalling 57 Berchtold Chromophare F300 exam lights because a tolerance issue may cause the equipment to fall, posing a risk of serious injury.
Product
Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2279-2017·2017-06-14
Arrow International Recalls CVC Kits Due to Needlestick Injury Risk
Arrow International is recalling specific CVC kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk to medical personnel.
Product
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2275-2017·2017-06-14
Arrow Central Venous Catheter Kits Recalled for Needlestick Injury 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 Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2278-2017·2017-06-14
Arrow International Recalls Multi-Lumen CVC Kits Due to Needlestick Risk
Arrow International is recalling specific multi-lumen central venous catheter kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2287-2017·2017-06-14
Arrow International Recalls Access Kits Due to Needlestick Injury Risk
Arrow International is recalling Access Kits with Maximal Barrier Precautions because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow¿ Access Kit with Maximal Barrier Precautions 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-2272-2017·2017-06-14
Arrow Central Venous Catheter Kits Recalled for Needlestick Injury Risk
Arrow International is recalling certain 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), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2289-2017·2017-06-14
Arrow Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because packaged BD Eclipse Needles 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-2286-2017·2017-06-14
Arrow PICC Recall Due to Safety Cover Disengagement and Needlestick Risk
Arrow International is recalling Arrow PICC devices with Chlorag+ard Technology because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2261-2017·2017-06-14
Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters. The Arrow Percutaneous Sheath Introducer permits venous access and catheter…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2285-2017·2017-06-14
Arrow PICC Kit Recalled Due to BD Eclipse Needle Safety Cover Issues
Arrow International is recalling certain PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2273-2017·2017-06-14
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 Two-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) treatment…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2300-2017·2017-06-14
Arrow Arterial Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Arterial 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-2295-2017·2017-06-14
Arrow International Recalls Femoral Arterial Line Catheterization Kits
Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Femoral 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-2267-2017·2017-06-14
Arrow International Recalls Central Catheters Due to Needlestick Injury Risk
Arrow International is recalling 43,394 units of central catheters because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2266-2017·2017-06-14
Arrow PICC Recall Initiated Due to Needlestick Injury Risk
Arrow International is recalling 43,394 units of Arrow PICC with Chlorag+ard Technology due to safety cover disengagement and needlestick injury risks 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
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2257-2017·2017-06-14
Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits due to safety cover disengagement on packaged BD Eclipse Needles, 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 Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2293-2017·2017-06-14
Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling specific Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2304-2017·2017-06-14
Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters The Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2292-2017·2017-06-14
Arrow International Recalls Central Catheters Due to Needlestick Injury Risk
Arrow International is recalling specific central catheters because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
"Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2321-2017·2017-06-14
OrthoPediatrics Recalls Response BandLoc Tensioner Instruments Due to Band Rupture Risk
OrthoPediatrics Corp is recalling 82 Response BandLoc 5.5/6.0 Tensioner Instruments because over-tensioning can damage the band, causing it to rupture during spine surgery.
Product
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Category
Medical Device
Distribution
6 states

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19526–19550 of 27682