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

12351–12375 of 13837

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-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-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-0538-2022·2022-02-09
FDA Recalls DIXI Medical Microdeep Depth Electrodes Due to Packaging Defect
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes nationwide due to potential internal packaging deformation that could compromise the device's sterile barrier.
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-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-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
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-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-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-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-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-0535-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode Sterile Barrier Compromise Recall
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes used in neurological monitoring and stimulation due to potential deformation of the internal sterile packaging. The compromised sterile barrier could allow contamination before use.
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-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-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-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-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-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-0541-2022·2022-02-09
DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility
DIXI MEDICAL USA is recalling 1792 Microdeep Depth Electrodes due to potential deformation of the internal blister pack that could compromise the sterile barrier when the device is removed from its 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-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
ModerateFDA (Devices)·Z-0558-2022·2022-02-09
Celltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed
Celltrion USA Inc. is recalling 162,000 units of the European version of its DiaTrust COVID-19 Ag Rapid Test, which was not approved for U.S. distribution. The test packaging and labeling differ from the FDA-approved U.S. version.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0551-2022·2022-02-09
Olympus Spiration Valve System mislabeled with incorrect model number
Olympus Corporation is recalling 35 units of the Spiration Valve System (SVS-V9-00) due to a mislabeled patient charge label indicating model SVS-V7-00 instead. The incorrect label could confuse healthcare providers about which valve was implanted.
Product
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0544-2022·2022-02-09
Medical device control product pouches mislabeled with incorrect catalog number
Microbiologics Inc recalls KWIK-STIK IVD control product (lot 323-108-7) containing 47 packs due to pouches being labeled with incorrect catalog number 726-57-10 instead of correct labeling.
Product
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0546-2022·2022-02-09
Medical Device QC Kit Component Bears Incorrect Expiration Date Label
Microbiologics Inc is recalling KWIK-STI(TM) GBS QC Set components with a mislabeled expiration date. The Lactobacillus acidophilus component was labeled 7/31/2020 instead of 7/31/2022.
Product
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0543-2022·2022-02-09
Microbiologics KWIK-STIK Candida Parapsilosis Control Has Incorrect Pouch Labeling
Microbiologics is recalling KWIK-STIK Candida parapsilosis diagnostic controls with lot 726-57-10 because some pouches are labeled with incorrect catalog number (323-108-7 instead of 0726P).
Product
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Category
Medical Device
Distribution
10 states

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12351–12375 of 13837