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

33476–33500 of 40325

HighFDA (Devices)·Z-1146-2015·2015-03-04
Biomet Spine Recalls Out-of-Specification 5.5 mm Rod Set Screws
Biomet Spine is recalling 1,999 5.5 mm rod set screws because they are out of specification. The devices are used in spinal fixation constructs.
Product
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2015·2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 74 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.
Product
NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, 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
HighFDA (Devices)·Z-1177-2015·2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
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 risk of infection.
Product
NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, 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 Monitoring Systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1161-2015·2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 30 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.
Product
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683. 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-1166-2015·2015-03-04
Navilyst Medical Recalls NAMIC Left Heart Cath Kits Due to Sterility Concerns
Navilyst Medical is recalling 62 units of NAMIC Left Heart Cath Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach.
Product
NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1199-2015·2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling specific lots of 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 H965601206511, REF/Catalog No. 60120651, 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
HighFDA (Devices)·Z-1160-2015·2015-03-04
Navilyst NAMIC Convenience Kit Recall Due to Sterility Risk
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, UPN H7496006044121, REF/Catalog No. 600604412, 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 Monitoring…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2015·2015-03-04
Spacelabs Healthcare Recalls qube Compact Monitors for Boot Failure
Spacelabs Healthcare is recalling 2,955 qube Compact Monitors because they may fail to boot up or reset to factory defaults after power on.
Product
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other…
Category
Medical Device
Distribution
0 states
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

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