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

33576–33600 of 40449

HighFDA (Devices)·Z-1213-2015·2015-03-04
Norwex SilverCare Junior Toothbrush Recalled for Detaching Heads
Norwex USA Inc. is recalling SilverCare Junior toothbrushes because the head can detach from the handle, posing a choking hazard.
Product
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on…
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1152-2015·2015-03-04
Navilyst NAMIC Convenience Kits Recalled for Potential Sterility Breach
Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.
Product
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1148-2015·2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 15 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.
Product
NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1189-2015·2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 2,502 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.
Product
NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1208-2015·2015-03-04
Biomet Shoulder Implant Recall Due to Missing Taper Adaptor
Biomet is recalling specific shoulder implant baseplates because a taper adaptor is missing from the packaging, which may delay surgery.
Product
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1141-2015·2015-03-04
Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference
Intuitive Surgical is recalling 3,282 EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.
Product
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1214-2015·2015-03-04
GE Healthcare Recalls Centricity PACS Workstation Due to Exam Merge Failure
GE Healthcare is recalling 128 Centricity PACS Workstation systems because a software defect may cause exam records to go missing in single Study Mode.
Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1143-2015·2015-03-04
Angiodynamics Recalls Starburst MRI Electrode Devices Due to Marking Error
Angiodynamics is recalling 43 Starburst MRI Semi-Flex Electrode Devices because a printed distance mark is incorrectly located 4cm from the tip instead of 5cm.
Product
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-1147-2015·2015-03-04
Medtronic Neurostimulator Recall Due to Inaccurate Battery Longevity Estimates
Medtronic is recalling specific neurostimulator models because enabling cycling at certain settings may decrease battery life and cause inaccurate longevity estimates on the programmer.
Product
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1142-2015·2015-03-04
Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference
Intuitive Surgical is recalling EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.
Product
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1035-2015·2015-02-25
GE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay
GE Healthcare is recalling MRI systems because a disconnected MRU could delay the removal of ferrous objects, posing a life-threatening injury risk.
Product
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1061-2015·2015-02-25
Alltech Medical Systems Recalls Two MRI Systems Due to Safety Feature Failure
Alltech Medical Systems America Inc is recalling two Echostar Spica 1.5T MRI systems because the emergency magnetic field lowering feature may not work correctly.
Product
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1128-2015·2015-02-25
Mako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction
Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application RIO because the surgical burr may continue spinning outside the intended boundary after controls are released.
Product
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1126-2015·2015-02-25
CME America Recalls BodyGuard 323 Infusion Pumps for Over-Delivery Risk
CME America is recalling BodyGuard and BodyGuard 323 infusion pumps due to a potential for over-delivery of medication.
Product
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1127-2015·2015-02-25
Nidek MC-500 Laser Photocoagulator Recalled for Spot Size Control Defect
Nidek Inc is recalling 16 MC-500 Multicolor Laser Photocoagulators because the spot size control may turn by itself, posing a risk of unintended laser delivery.
Product
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1116-2015·2015-02-25
Terumo HX2 Temperature Management System Recalled for Valve Malfunction
Terumo is recalling 103 HX2 Temperature Management Systems because a malfunctioning mixing valve can cause loss of cooling or heating capability during surgery.
Product
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1124-2015·2015-02-25
Teleflex Recalls RUSCH Endotracheal Tubes for Cuff Diameter Labeling Error
Teleflex is recalling RUSCH Curved Reinforced Endotracheal Tubes because the labeled cuff diameter does not match the actual cuff diameter, though the actual product meets specifications.
Product
R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1117-2015·2015-02-25
Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use
Intuitive Surgical is recalling Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.
Product
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1129-2015·2015-02-25
Cincinnati Sub-Zero CT-99 Cold Therapy Pad Recall for Seal Separation
Cincinnati Sub-Zero is recalling CT-99 cold therapy pads because seals may separate during use, causing water leaks.
Product
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1122-2015·2015-02-25
Biomet Recalls Specific Lot of Mallory Head Acetabular Shell Components
Biomet is recalling 17 units of the Mallory Head 4 Finned Acetabular Shell 50 mm (Lot 364600) due to a packaging mix-up with a different shell size.
Product
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1121-2015·2015-02-25
Pulsiocath PiCCO ProAQT Monitoring Kit Recalled for Packaging Defects
Pulsion Medical Inc is recalling 90 units of the Pulsiocath PiCCO ProAQT Monitoring Kit due to cracks and holes found in the primary packaging.
Product
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1119-2015·2015-02-25
Siemens Artis One Angiography System Recalled for Monitor Failure
Siemens Medical Solutions is recalling one Artis One angiography system because the monitor may fail and require a power cycle to resume operation.
Product
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1123-2015·2015-02-25
Biomet Recalls Acetabular Shell Components Due to Packaging Mix-Up
Biomet is recalling specific acetabular shell components for hip prostheses due to a packaging mix-up between two different product lots.
Product
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1118-2015·2015-02-25
Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use
Intuitive Surgical is recalling 12,467 Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.
Product
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1130-2015·2015-02-25
Haemonetics TEG Hemostasis System Level II Control Recall
Haemonetics is recalling specific lots of TEG Hemostasis System Level II Control kits because they produce high Maximum Amplitude results outside the expected quality control range.
Product
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
Category
Medical Device
Distribution
0 states

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