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 deaths or serious injuries are reported, 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

3851–3875 of 5038

SevereFDA (Devices)·Z-2676-2016·2016-09-07
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported field failures involving shaft rotation interruption or jaws not opening.
Product
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation o
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2677-2016·2016-09-07
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported shaft rotation interruptions and jaw opening failures.
Product
CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2681-2016·2016-09-07
Philips PCR Compano Basic Reader Recalled for Power Supply Fire Hazard
Philips is recalling 388 PCR Compano Basic Reader units because a defective power supply component can burn and release smoke.
Product
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Category
Medical Device
Distribution
41 states
SevereFDA (Devices)·Z-2675-2016·2016-09-07
Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.
Product
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2610-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture
Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2649-2016·2016-08-31
Bovie Precise 360 Handpiece Recalled Due to Incomplete Tip Bond
Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
Product
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2596-2016·2016-08-31
Conmed Dual Dispersive Electrodes Recalled for Burn Risk
Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
Product
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2665-2016·2016-08-31
Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their batteries may overheat, melt, or char.
Product
Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity mea
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2618-2016·2016-08-31
Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture
Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2619-2016·2016-08-31
Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture
Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2620-2016·2016-08-31
Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture
Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.
Product
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2622-2016·2016-08-31
Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture
Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2597-2016·2016-08-31
Conmed Pediatric ThermoGard Electrodes Recalled for Burn Risk
Conmed is recalling Pediatric ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
Product
Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2617-2016·2016-08-31
Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2016·2016-08-31
Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets
Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.
Product
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for eva
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2662-2016·2016-08-31
Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader because the batteries may overheat, melt, or char.
Product
Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain informati
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2616-2016·2016-08-31
Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets
Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.
Product
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2613-2016·2016-08-31
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture
Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.
Product
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2614-2016·2016-08-31
Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture
Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2650-2016·2016-08-31
Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.
Product
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2651-2016·2016-08-31
Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk
Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.
Product
Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardiov
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2660-2016·2016-08-31
Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.
Product
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2621-2016·2016-08-31
Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2611-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters
Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angio
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2664-2016·2016-08-31
Tecan Infinite M1000 Microplate Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling the Infinite M1000 microplate reader because its batteries may overheat, melt, or char.
Product
Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the
Category
Medical Device
Distribution
19 states

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3851–3875 of 5038