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

19426–19450 of 27682

HighFDA (Devices)·Z-2653-2017·2017-07-05
Shimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks
Shimadzu Medical Systems is recalling ceiling-type X-ray tube supports because cracks may develop on the tube holding shaft, posing a risk of equipment failure.
Product
SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2640-2017·2017-07-05
Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors
Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient care.
Product
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2651-2017·2017-07-05
Carestream Recalls DRX-Revolution Mobile X-Ray Systems Due to Assembly Defect
Carestream Health Inc is recalling DRX-Revolution Mobile X-Ray Systems because missing screws could cause the tube and yoke assembly to separate.
Product
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2017·2017-07-05
Smith & Nephew Recalls Legion Tib Cone Impactor Heads Due to Adhesive Error
Smith & Nephew is recalling 46 units of Legion Tib Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.
Product
LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2624-2017·2017-07-05
Smith & Nephew Recalls Legion Fem Cone Impactor Heads Due to Adhesive Error
Smith & Nephew is recalling 36 units of Legion Fem Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.
Product
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2634-2017·2017-07-05
Mindray Recalls TI Transport Monitor Battery Packs Due to Overheating
Mindray is recalling 2,718 TI Transport Monitor battery packs because two reports indicated the packs overheated.
Product
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2017·2017-07-05
Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification
Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.
Product
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2633-2017·2017-07-05
Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure
Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.
Product
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2630-2017·2017-07-05
Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue
Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.
Product
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2654-2017·2017-07-05
Shimadzu RADspeed Pro X-Ray Systems Recalled for Tube Shaft Cracks
Shimadzu is recalling RADspeed Pro stationary x-ray systems because cracks may develop on the tube holding shaft, posing a risk of equipment failure.
Product
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2642-2017·2017-07-05
Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure
Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.
Product
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2622-2017·2017-07-05
Recall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector
Covidien LLC is recalling 194,851 units of the Endo Peanut 5mm Auto Suture Blunt Dissector because the cotton tip may disengage due to insufficient adhesive.
Product
Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2655-2017·2017-07-05
Shimadzu FDR Visionary X-Ray System Recalled for Tube Shaft Cracks
Shimadzu is recalling FDR Visionary x-ray systems because cracks may develop on the tube holding shaft. The recall covers 1,673 units distributed in the US, Canada, and Japan.
Product
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2224-2017·2017-06-28
Vascular Solutions Recalls Venture Catheters Due to Material Detachment Risk
Vascular Solutions, Inc. is voluntarily recalling Venture RX, OTW, and CS catheters because material may detach from the distal tip during use.
Product
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2616-2017·2017-06-28
DePuy Mitek LATARJET Coracoid Drill Recalled for Breakage Risk
DePuy Mitek is recalling LATARJET Coracoid Drills because the Combo Screw Driver tip may break during surgery.
Product
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-2617-2017·2017-06-28
DePuy Mitek LATARJET Drill Tip Recall Due to Breakage Risk
DePuy Mitek is recalling LATARJET Coracoid Top Hat Drills because the Combo Screw Driver tip may break during surgery.
Product
DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2602-2017·2017-06-28
Medtronic Recalls MiniMed 620G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 6,573 MiniMed 620G insulin infusion pumps because the keypad may become unresponsive and the pump may become temporarily stuck.
Product
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2605-2017·2017-06-28
Medtronic Recalls MiniMed 670G Insulin Pumps Due to Keypad Issues
Medtronic is recalling 117,239 MiniMed 670G insulin pumps because the keypad may become unresponsive and the pump may become temporarily stuck.
Product
MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2619-2017·2017-06-28
DePuy Mitek LATARJET Extraction Driver Recalled for Breakage Risk
DePuy Mitek is recalling 115 units of the LATARJET EXPERIENCE Extraction Driver because the tip may break during surgery when used at an angle.
Product
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2621-2017·2017-06-28
Omega Medical Imaging Recalls Elevating Monitor Suspension Pillars
Omega Medical Imaging is recalling 6 units of 2 over 2 Elevating Monitor Suspension pillars because the column may drop and fail to rise.
Product
Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2603-2017·2017-06-28
Medtronic Recalls MiniMed 630G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 65,959 MiniMed 630G insulin pumps because the device may become temporarily stuck and the keypad may become unresponsive.
Product
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2618-2017·2017-06-28
DePuy Mitek Top Hat Tap Screw Driver Tip Recall
DePuy Mitek is recalling 153 units of the LATARJET EXPERIENCE Top Hat Tap because the Combo Screw Driver tip may break during surgery.
Product
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2604-2017·2017-06-28
Medtronic Recalls MiniMed 640G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 117,239 MiniMed 640G insulin pumps because the keypad may become unresponsive, potentially preventing users from adjusting insulin delivery.
Product
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2592-2017·2017-06-28
Ion Beam Applications Recalls Proteus 235 Medical Devices
Ion Beam Applications S.A. is recalling 18 Proteus 235 systems due to potential dark current issues in Pencil Beam Scanning mode.
Product
Proteus 235
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2615-2017·2017-06-28
DePuy Mitek LATARJET Combo Screw Driver Recalled for Breakage Risk
DePuy Mitek is recalling 173 LATARJET Combo Screw Drivers because the tip may break during surgery when used at an angle.
Product
DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Category
Medical Device
Distribution
8 states

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19426–19450 of 27682