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

13101–13125 of 13837

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-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-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-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 Mod
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-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 selecte
Category
Medical Device
Distribution
5 states
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 blo
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2419-2021·2021-09-15
MRI Tabletop May Not Move Properly in Manual Mode
The patient tabletop on affected Philips Ingenia Elition MRI systems may not move completely in or out during manual operation, potentially delaying patient evacuation from the device.
Product
Ingenia Elition X-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
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-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-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
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-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
HighFDA (Devices)·Z-2405-2021·2021-09-08
Discectomy Device Kit Class II recall due to sterile barrier compromise
Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.
Product
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Category
Medical Device
Distribution
0 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-2400-2021·2021-09-08
TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments
DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.
Product
TRUMATCH CT CUT GUIDE FEM L- 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-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
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-2409-2021·2021-09-08
Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution
Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.
Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
Category
Medical Device
Distribution
Distributed nationwide
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-2406-2021·2021-09-08
Monaco RTP System software defect may cause incorrect radiation therapy dose calculations
Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.
Product
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2398-2021·2021-09-08
Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error
DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.
Product
TRUMATCH CT CUT GUIDE KIT L- 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-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-2388-2021·2021-09-08
Surgical arm suspension kits recalled due to sterilization concerns
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.
Product
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Category
Medical Device
Distribution
Distributed nationwide

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13101–13125 of 13837