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 13816

HighFDA (Devices)·Z-0599-2022·2022-02-16
GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defects
GE Healthcare is recalling MR superconducting magnets used in SIGNA Voyager MRI systems due to cryogen ventilation systems that may not meet venting requirements. The recall affects 17,228 devices.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0584-2022·2022-02-16
KWIK-STIK Quality Control Sets recalled for potential bacterial contamination
Microbiologics Inc is recalling KWIK-STIK QC Sets and Panels due to potential contamination with E. coli and Staphylococcus species. The affected product was distributed worldwide to laboratory testing facilities.
Product
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that conta
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2022·2022-02-16
MIC Percutaneous Endoscopic Gastrostomy Kits Recalled for Oversized Retention Bolster
Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy (PEG) Kit because the external retention bolster may be oversized relative to the tube. Approximately 2,652 units have been distributed in the US, Canada, and Chile.
Product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0610-2022·2022-02-16
GE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect
GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0591-2022·2022-02-16
GE Healthcare MRI magnets recalled for cryogen ventilation defect
GE Healthcare is recalling 17,228 MRI system magnets with potential cryogen ventilation defects. No injuries have been reported.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0579-2022·2022-02-16
Baxter CAPD Transfer Sets may crack or leak when exposed to cleaning chemicals
Baxter CAPD MiniCap Transfer Set II units may leak or crack when cleaned with chemicals including bleach, hydrogen peroxide, or solvents. The recall affects 8,928 units distributed worldwide.
Product
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0569-2022·2022-02-16
R82 by ETAC Push Brace for High-Low recalled due to cracking hazard
The R82 by ETAC Push Brace for High-Low is being recalled because the chrome surface can crack during use, potentially cutting users. Approximately 396 units manufactured between August and October 2021 are affected.
Product
R82 by ETAC Push Brace for High-Low
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0588-2022·2022-02-16
Diagnostic Quality Control Microorganism Set Fails Gentamicin Susceptibility Specifications
Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.
Product
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2022·2022-02-16
LYFO DISK Streptococcus Pneumoniae Culture Kit Recalled for Bacterial Contamination
Microbiologics Inc is recalling LYFO DISK Streptococcus pneumoniae microorganism culture kits (lot 947-126-1) distributed worldwide due to potential contamination with E. coli, Staphylococcus epidermidis, and S. warneri.
Product
LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorg
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0617-2022·2022-02-16
GE Healthcare MRI systems recalled for cryogenic ventilation defect
GE Healthcare MRI systems may have cryogenic ventilation systems that do not meet venting requirements. The recall affects 17,228 devices distributed nationwide and globally. Healthcare facilities should contact GE Healthcare for corrective actions.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0561-2022·2022-02-16
Gentueri Viral Transport Medium Kit recalled due to sterility failure
Gentueri Inc is recalling Viral Transport Medium Kits due to failed sterility testing and evidence of contamination. The recall affects 13,975 units distributed to Illinois, Nebraska, and Wisconsin.
Product
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0630-2022·2022-02-16
BD Veritor Plus Analyzer may overheat when using unauthorized power adapter
BD Veritor Plus Analyzer devices may overheat or catch fire if powered with an unauthorized AC adapter instead of the manufacturer-provided one. The recall affects approximately 129,848 analyzers distributed worldwide.
Product
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0606-2022·2022-02-16
GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation
GE Healthcare SIGNA HFO/I MR Systems may have cryogen ventilation systems that do not meet venting requirements. Approximately 17,228 systems are affected nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I 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
HighFDA (Devices)·Z-0589-2022·2022-02-16
QC Blood Culture Identification Panel Recall for Incorrect Antibiotic Susceptibility Test Results
Microbiologics recalls KWIK-STIK blood culture identification quality control panels due to incorrect susceptibility test results. High-level Gentamicin Synergy values were out of specification, risking inaccurate diagnostic guidance.
Product
QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0598-2022·2022-02-16
GE Healthcare MRI Systems with Potentially Non-Compliant Cryogen Ventilation Systems
GE Healthcare has recalled approximately 17,228 MRI systems due to cryogen ventilation systems that may not meet required venting standards. The issue affects systems distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0611-2022·2022-02-16
GE Healthcare MRI Systems Recalled for Inadequate Cryogenic Ventilation
GE Healthcare has recalled 17,228 MRI systems because the cryogenic ventilation system does not meet safety requirements. Systems were distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
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
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-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-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
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-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

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12301–12325 of 13816