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

10376–10400 of 27470

HighFDA (Devices)·Z-0604-2022·2022-02-16
GE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect
GE Healthcare recalled 17,228 superconducting magnets, a component of SIGNA 1.5T MR systems, due to a cryogen ventilation system that may not meet venting requirements. Systems are distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0585-2022·2022-02-16
Quality Control Kit for Antibiotic Susceptibility Testing Returning Incorrect Results
Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.
Product
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0480-2022·2022-02-09
COVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
CovClear COVID-19 Rapid Antigen Test kits (284,575 units) were distributed nationwide without FDA marketing approval, clearance, or authorization. All lots are recalled.
Product
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0481-2022·2022-02-09
COVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale
Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0530-2022·2022-02-09
Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures
Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0529-2022·2022-02-09
Baxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure
Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.
Product
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0550-2022·2022-02-09
OXY-1 System Console Experiences Power Interruption During Use
OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.
Product
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0554-2022·2022-02-09
HARDY DIAGNOSTICS CatScreen diagnostic kit recalled due to improper storage
HARDY DIAGNOSTICS CatScreen test kits (Model HADZ110) are recalled because units were stored in temperature-controlled settings instead of refrigeration. Improper storage may compromise product effectiveness.
Product
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0548-2022·2022-02-09
INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled
Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.
Product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0549-2022·2022-02-09
Philips eCareManager versions recalled due to unapproved Sentry Score software
Philips is recalling certain versions of eCareManager software because the Sentry Score feature was not approved by FDA prior to distribution. Users should contact Philips for updated information.
Product
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2022·2022-02-09
DIXI Medical Depth Electrodes recalled for potential sterile packaging defect
DIXI MEDICAL USA is recalling 461 Microdeep Depth Electrodes. The internal blister packaging may deform, potentially compromising the sterile barrier when removed from the protective Tyvek bag.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0553-2022·2022-02-09
ARIES HSV 1&2 Diagnostic Cassettes May Leak, Affecting Test Results
Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A) due to a confirmed 0.9% leak rate. Leaking cassettes may cause incorrect or delayed test results.
Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2022·2022-02-09
Vagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
LivaNova's PerenniaDURA vagus nerve stimulation leads may have insufficient silicone tubing thickness due to a manufacturing issue. This could result in unintended stimulation delivery or loss of therapy if the tubing is breached.
Product
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0552-2022·2022-02-09
Premier Rotaclone Medical Device Recalled Due to Improper Storage Conditions
Medline Industries is recalling 34 units of the Premier Rotaclone (Lot 696004N116) due to improper storage in temperature-controlled settings instead of required refrigeration. This may affect device performance or safety.
Product
Premier Rotaclone, Rx only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2022·2022-02-09
Spinal Fusion Implant Insert Recalled for Assembly Defect
XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert for the Axle Interspinous Fusion System due to a manufacturing defect that prevents proper assembly of crossbar plates. The defect could affect the device's function during spinal fusion procedures.
Product
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0534-2022·2022-02-09
Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk
DIXI Medical is recalling 484 Microdeep Depth Electrodes nationwide due to potential deformation of internal packaging that could compromise the sterile barrier of these brain recording devices.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0557-2022·2022-02-09
Chameleon PTA Balloon Catheter difficult protector sleeve removal risk
The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.
Product
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2022·2022-02-09
DIXI Microdeep Depth Electrode packaging deformation poses sterility risk
DIXI Medical USA is recalling 2,141 Microdeep Depth Electrodes nationwide due to potential deformation of the blister pack that could compromise the sterile barrier when devices are removed from their Tyvek bags.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2022·2022-02-09
DIXI Microdeep Depth Electrode sterile barrier packaging defect
DIXI Medical Microdeep Depth Electrodes are recalled due to potential deformation of the blister pack packaging that could compromise the sterile barrier. 345 units nationwide are affected.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2022·2022-02-09
Ultrasound System Software Calculation Error in Siemens ACUSON Sequoia
Software error in certain Siemens ACUSON Sequoia ultrasound systems causes measurement values to be overestimated, potentially resulting in patient misdiagnosis.
Product
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0537-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode Packaging Defect Threatens Sterile Barrier
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential packaging deformation that could compromise the sterile barrier. Approximately 2,720 units were distributed nationwide for use in brain recording and stimulation procedures.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2022·2022-02-09
Cryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity
Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.
Product
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0555-2022·2022-02-09
Young Dental Sterilization Indicator Labels May Contain Wrong Type
YOUNG DH Dry Heat Indicator Labels used in healthcare sterilization may contain TTS Indicator Labels instead. Healthcare providers should verify package contents before use to ensure proper sterilization monitoring.
Product
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0542-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode packaging defect may compromise sterility
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential deformation of the internal packaging (blister pack) that could compromise the sterile barrier. The recall affects 365 units distributed nationwide.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0556-2022·2022-02-09
Pelvic floor repair device may lack required packaging component
FEMSelect Ltd is recalling 141 units of the EnPlace trans-vaginal pelvic floor repair system because certain lots may not have been packaged with the required Channel Tube Limiter accessory.
Product
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the
Category
Medical Device
Distribution
Distributed nationwide

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10376–10400 of 27470