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

26251–26275 of 40357

HighFDA (Devices)·Z-2626-2017·2017-07-05
EOS Imaging Recalls ROTH MOBELI Grab Handles for Detachment Risk
EOS Imaging is recalling ROTH MOBELI grab handles because they could detach, posing a fall risk to patients if operators do not follow instructions.
Product
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2629-2017·2017-07-05
Olympus Recalls High Frequency Resection Electrodes Due to Wire Breakage
Olympus Corporation of the Americas is recalling 1,264 High Frequency Resection Electrodes because loop wires may break at the distal end.
Product
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2637-2017·2017-07-05
Beckman Coulter Access System-Free T4 Assay Recalled for Biotin Interference
Beckman Coulter is recalling Access System-Free T4 Assay kits because they are susceptible to biotin interference, which may affect test results.
Product
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Category
Medical Device
Distribution
3 states
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
ModerateFDA (Devices)·Z-2643-2017·2017-07-05
Merge Healthcare Recalls MasimoSET SpO2 Sensors for Display Issues
Merge Healthcare is recalling 65 MasimoSET LNOP DCI adult SpO2 reusable sensors because cables may stop displaying patient SpO2, causing slight delays in care.
Product
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2652-2017·2017-07-05
AGFA Healthcare Recalls IMPAX Cardiovascular Software Due to Incorrect Findings
AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software because it displayed incorrect aneurysm findings in NIV reports.
Product
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2635-2017·2017-07-05
Beckman Coulter Access Total T3 Immunoassay Recalled for Biotin Interference
Beckman Coulter is recalling Access Total T3 immunoassays because they are susceptible to biotin interference, which may affect test results.
Product
Access Total T3, A34435H, Catalog No. 33830
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2636-2017·2017-07-05
Beckman Coulter Access Thyroglobulin Recalled for Biotin Interference
Beckman Coulter is recalling Access Thyroglobulin immunoassays because they are susceptible to biotin interference, which may affect test results.
Product
Access Thyroglobulin, A34085G, Catalog No. 33860
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2647-2017·2017-07-05
Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stems
Onkos Surgical is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.
Product
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2646-2017·2017-07-05
Onkos Surgical Recalls ELEOS Limb Salvage System Segmental Stem Due to Labeling Error
Onkos Surgical is recalling four units of the ELEOS Limb Salvage System Segmental Stem because the device collar size was incorrectly labeled as 25 mm instead of 32 mm.
Product
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2632-2017·2017-07-05
3M Ranger Pressure Infusor Recalled for Pressure Specification Deviation
3M is recalling one Ranger Pressure Infusor, Model 145, because it produced pressure slightly below manufacturing specifications.
Product
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2641-2017·2017-07-05
Merge Healthcare Recalls Masimo SPO2 Sensors for Display Failure
Merge Healthcare is recalling Masimo SPO2 ear clip sensors because cables may stop displaying SpO2 readings, causing slight delays in patient care.
Product
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), 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 monitoring of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2644-2017·2017-07-05
Exactech Novation Calcar Planer Guide Tip Recalled for Labeling Clarification
Exactech is recalling 477 Novation Calcar Planer Guide Tips to update labeling with a caution about instrument breakage.
Product
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for…
Category
Medical Device
Distribution
Distributed nationwide

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26251–26275 of 40357