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

31676–31700 of 40325

ModerateFDA (Devices)·Z-0124-2016·2015-10-21
Synthes Humerus Plates Recalled for Incorrect Part Number Labeling
Synthes (USA) Products LLC is recalling 36 units of VA-LCP Humerus Plates because one part number was incorrectly etched on the device.
Product
Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0017-2016·2015-10-21
Toshiba Aquilion CT System Recall for Data Loss Risk
Toshiba is recalling 459 Aquilion CT Systems because specific scanning operations may prevent raw data from being saved.
Product
Toshiba Aquilion CT System TSX-302A
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0015-2016·2015-10-21
Toshiba Aquilion CT System Recalled for Data Loss Risk
Toshiba American Medical Systems is recalling 459 Aquilion CT Systems because specific scanning operations may cause raw data to not be saved.
Product
Toshiba Aquilion CT System TSX-301B
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0013-2016·2015-10-21
Toshiba Aquilion CT System Recall for Data Loss Risk
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.
Product
Toshiba Aquilion CT System TSX-101A
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0127-2016·2015-10-21
Arrow International Recalls PICC Catheters Due to Labeling Inaccuracy
Arrow International Inc is recalling 4FR Single Lumen Pressure Injectable PICC catheters because the instructions state they withstand 10 pressure injections, but they are only tested for 5.
Product
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0126-2016·2015-10-21
Synthes Screw Inserter Recalled for Incorrect Etched Graphics
Synthes (USA) Products LLC is recalling 793 units of the Screw Inserter because the etched graphics may not correspond to the instrument's actual angle.
Product
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0016-2016·2015-10-21
Toshiba Aquilion CT System Recall for Potential Data Loss
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.
Product
Toshiba Aquilion CT System TSX-301C
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0122-2016·2015-10-21
Alere Cholestech LDX Multianalyte Controls Recalled for Incorrect Ranges
Alere San Diego is recalling Cholestech LDX Multianalyte Controls because the assigned control ranges for Total Cholesterol and Triglycerides are incorrect.
Product
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0117-2016·2015-10-21
Natus Neurology Recalls NicoletOne Software Due to Signal Obstruction
Natus Neurology is recalling NicoletOne Software v5.94 because a persistent impedance check signal obscures EEG data, potentially affecting clinical monitoring.
Product
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0018-2016·2015-10-21
Toshiba Aquilion CT System Recall for Data Loss Risk
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may cause acquired raw data to not be saved.
Product
Toshiba Aquilion CT System TSX-303A
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0014-2016·2015-10-21
Toshiba Aquilion CT System Recall for Data Loss Risk
Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.
Product
Toshiba Aquilion CT System TSX-301A
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0116-2016·2015-10-21
Concentric Medical Recalls One Distal Access Catheter for Distribution Error
Concentric Medical Inc is recalling one Distal Access Catheter that was intended for distribution in Korea but was found at a US location in Kentucky.
Product
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0059-2016·2015-10-14
FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0111-2016·2015-10-14
DePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints
DePuy Orthopaedics is voluntarily recalling select lots of the Specialist 2 Intramedullary Rod 400mm Instrument because the rod has fractured, leaving portions inside patients.
Product
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with…
Category
Medical Device
Distribution
40 states
SevereFDA (Devices)·Z-0082-2016·2015-10-14
FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.
Product
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0033-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0074-2016·2015-10-14
FDA Recalls Robotic Laparoscopic Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 144 robotic laparoscopic surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0075-2016·2015-10-14
FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves may have splits or holes that compromise sterility.
Product
regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0092-2016·2015-10-14
FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 214 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0078-2016·2015-10-14
FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0052-2016·2015-10-14
Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0070-2016·2015-10-14
FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 144 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0068-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Pediatric Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric heart surgical kits due to potential sterility compromise from defective equipment gloves.
Product
regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0112-2016·2015-10-14
Elekta Monaco Radiation Treatment Planning System Software Recall
Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.
Product
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0102-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Titanium Rib Surgical Kits
Resource Optimization & Innovation LLC is recalling 62 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states

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31676–31700 of 40325