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 deaths or serious injuries are reported, 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

13076–13100 of 13816

HighFDA (Devices)·Z-2418-2021·2021-09-15
MRI Magnetic Resonance System Tabletop May Fail to Move in Manual Mode
Philips Ingenia Elition S-a MRI systems may have tabletop movement failure in manual mode, potentially delaying patient evacuation from the scanner bore and treatment. This affects 64 units distributed worldwide.
Product
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2427-2021·2021-09-15
Philips HEARTSTART Infant/Child Defibrillator Pads Recalled for Incorrect Labeling
Philips infant/child defibrillator pads are recalled due to incorrect labeling that could delay therapy or result in lower energy delivery than indicated.
Product
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2425-2021·2021-09-15
Medical Device Test Kit Requires More Frequent Calibration Than Labeled
Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.
Product
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2413-2021·2021-09-15
MRI device tabletop may fail to move completely in manual mode
Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units worldwide.
Product
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 7813
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2424-2021·2021-09-15
Atellica IM Diagnostic Test Kit Recalled for Calibration Interval Deficiency
Siemens Healthcare recalls the Atellica IM BR 27.29 diagnostic test kit because it does not maintain the claimed 10-day calibration interval; the required interval has been shortened to 3 days to ensure accurate results.
Product
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2416-2021·2021-09-15
Ingenia Ambition S-a MRI System tabletop may not move in manual mode
The Philips Ingenia Ambition S-a MRI system may not fully move its patient tabletop in or out of the bore during manual mode operation, potentially delaying patient evacuation and treatment.
Product
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2426-2021·2021-09-15
Medical diagnostic kit requires more frequent calibration than Instructions stated
The Instructions for Use for Siemens' Atellica IM BR 27.29 Test Kit incorrectly specified a 10-day calibration interval instead of 3 days. The manufacturer has updated the instructions for all kit lots.
Product
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2417-2021·2021-09-15
Philips MRI System Tabletop May Not Fully Move in Manual Mode
Philips Ingenia 3.0T-a MRI systems have an issue where the tabletop may not completely move in or out during manual operation. This could delay patient evacuation from the scanner bore and postpone medical treatment.
Product
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2440-2021·2021-09-15
COPAN FLOQSwabs Recalled Over Sterilization Integrity Failure
Copan Italia is recalling 3,029,400 COPAN FLOQSwabs distributed across the US due to sterilization integrity failures. The clinical sampling swabs cannot be guaranteed sterile due to data integrity issues at the contract sterilizer.
Product
COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2411-2021·2021-09-15
MRI diagnostic device tabletop may not move completely in manual mode
Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and out during manual operation, potentially delaying patient evacuation and treatment.
Product
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2414-2021·2021-09-15
MRI Tabletop Movement Malfunction in Manual Mode Affects Philips Ingenia Systems
Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual operation, potentially delaying patient evacuation and treatment.
Product
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2434-2021·2021-09-15
Proteus 235 Proton Therapy System May Display Misleading Popup Message
Ion Beam Applications is recalling certain Proteus 235 proton therapy systems because a misleading popup message may appear when the Oncology Information System disconnects, potentially causing treatment errors.
Product
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2435-2021·2021-09-15
Nihon Kohden NKV-550 Ventilator Recalled for Defective Pressure Regulator
Nihon Kohden NKV-550 Ventilators with certain serial numbers have a defective gas inlet pressure regulator that could cause malfunction or device check failure. The recall affects 1,999 units distributed globally.
Product
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2420-2021·2021-09-15
Medical Device Alert: Philips Ingenia MRI Tabletop Movement Failure
Philips Ingenia 3.0T MRI systems may fail to move the patient tabletop completely in or out, potentially delaying patient evacuation and treatment. 266 units are affected worldwide.
Product
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 7
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2437-2021·2021-09-15
Solero MTA Generator Requires Software Upgrade to Reduce Startup Error
Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.
Product
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2415-2021·2021-09-15
MRI System Tabletop May Fail to Move, Delaying Patient Evacuation
Philips MRI systems (Model 781260) may have a tabletop malfunction in manual mode that prevents complete movement, potentially delaying patient evacuation and treatment.
Product
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremitie
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2436-2021·2021-09-15
Solero MTA Generator requires software upgrade for startup error
Angiodynamics is recalling specific refurbished Solero MTA Generators due to Error 0001, which occurs during system startup. A software upgrade is required to reduce the error's frequency.
Product
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2439-2021·2021-09-15
Solero Generator PG requires software service for startup error
Angiodynamics is recalling 65 Solero Generator PG devices due to software Error 0001 that can occur during system startup. A software upgrade is required to reduce the incidence of this error.
Product
Solero Generator PG, Item No. H78712740000, Catalog No. 12740000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2438-2021·2021-09-15
Solero MTA Generator refurbished units require software servicing
Eight refurbished Solero MTA Generator units require software upgrades to reduce startup errors occurring in specific serial numbers.
Product
Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2383-2021·2021-09-08
CoolSculpting Elite System Software Error May Misreport Thermal Events
The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.
Product
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-2396-2021·2021-09-08
Surgical alignment software error recalled in patient-specific orthopedic instruments
DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.
Product
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2380-2021·2021-09-08
Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns
Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.
Product
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2387-2021·2021-09-08
Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue
Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.
Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2382-2021·2021-09-08
FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk
Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.
Product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2384-2021·2021-09-08
MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

13076–13100 of 13816