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

11026–11050 of 27441

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-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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2441-2021·2021-09-15
Guide Catheters Recalled for Potential Sterilization Defect
Mivi Neuroscience is recalling 491 MIVI Super 90 Guide Catheters due to potential nonsterility from a pouch seal defect. The catheters are used to guide microcatheters in vascular procedures.
Product
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a…
Category
Medical Device
Distribution
5 states
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-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-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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2421-2021·2021-09-15
MRI Tabletop Movement Failure May Delay Patient Evacuation and Treatment
Philips MRI systems may fail to move the examination tabletop in manual mode, potentially delaying patient evacuation and medical treatment.
Product
SmartPath to dStream for XR and 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2422-2021·2021-09-15
Philips Ingenia Ambition X MRI System Tabletop May Fail to Retract
Philips Ingenia Ambition X MRI systems may have tabletops that fail to move completely in manual mode, potentially delaying patient evacuation from the scanner and treatment. The issue affects 147 units distributed worldwide.
Product
Ingenia Ambition X- 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-2442-2021·2021-09-15
MIVI Super 90 8F Guide Catheter Recalled Due to Potential Sterility Defect
Mivi Neuroscience is recalling MIVI Super 90 8F Guide Catheters (investigational sterile devices) due to a potential pouch seal defect that could compromise product sterility.
Product
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2412-2021·2021-09-15
Philips Ingenia 1.5T MRI tabletop malfunction may delay patient evacuation
Philips is recalling 42 Ingenia 1.5T MRI systems because the tabletop may not fully move in or out in manual mode, potentially delaying patient evacuation and treatment.
Product
Ingenia 1.5T Evolution-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…
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2423-2021·2021-09-15
Arc Endocuff Vision endoscopic device recalled for packaging seal defects
Olympus recalls Arc Endocuff Vision endoscopic devices for packaging seal defects that may breach sterile barriers, risking patient infection. Approximately 711,157 units nationwide are affected.
Product
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be…
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-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-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…
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…
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…
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-2399-2021·2021-09-08
DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error
DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.
Product
TRUMATCH CT CUT GUIDE KIT 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-2395-2021·2021-09-08
Surgical instrument software error may cause limb misalignment
DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.
Product
TRUMATCH CT PIN GUIDE KIT 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-2410-2021·2021-09-08
COVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories
COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.
Product
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2378-2021·2021-09-08
Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure
Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.
Product
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2357-2021·2021-09-08
Medical Imaging Software Bug May Cause Incorrect X-ray Exposure
Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.
Product
CombiDiagnost R90 Software Version R1.0 and R1.1
Category
Medical Device
Distribution
Distributed nationwide

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11026–11050 of 27441