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

12301–12325 of 13802

HighFDA (Devices)·Z-0635-2022·2022-02-16
Acufex Access Advanced Positioning Kit Recalled for Missing Sterilization
Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.
Product
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0612-2022·2022-02-16
GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect
GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0613-2022·2022-02-16
GE MRI superconducting magnet systems recalled for cryogen ventilation system defect
GE Healthcare is recalling 17,228 MR superconducting magnet systems due to a potential cryogen ventilation system that does not meet venting requirements. The defect could pose safety risks to healthcare facilities and their staff.
Product
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0597-2022·2022-02-16
GE Healthcare MRI Magnets Recalled for Inadequate Cryogen Ventilation
GE Healthcare is recalling MRI magnets used in SIGNA MR355 and MR360 systems that could have cryogen ventilation systems not meeting venting requirements. These systems were distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0636-2022·2022-02-16
Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling
Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.
Product
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccan
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0582-2022·2022-02-16
Medical device reference standard contaminated with bacterial species
Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.
Product
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2022·2022-02-16
LYSO Disk microorganism culture device mislabeled with incorrect strain
Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.
Product
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0567-2022·2022-02-16
Dunnage Case Shipped Instead of THERAKOS CELLEX Photopheresis Kits
A dunnage case containing sterilization packaging was shipped in place of THERAKOS CELLEX Photopheresis Procedural Kits. The material is not intended for customer use and should not be used.
Product
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0621-2022·2022-02-16
GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 MRI superconducting magnets due to a potential cryogen ventilation system defect. The systems may not meet required venting specifications.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0581-2022·2022-02-16
Medical device lot number misprinted on packaging
Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.
Product
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Category
Medical Device
Distribution
0 states
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
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-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
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-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-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-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-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-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-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-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-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

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12301–12325 of 13802