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 the agency’s own highest classification or reported deaths or serious injuries, 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

13401–13425 of 39988

HighFDA (Devices)·Z-0170-2022·2021-11-03
GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.
Product
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0175-2022·2021-11-03
Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results
AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.
Product
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0172-2022·2021-11-03
Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.
Product
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
Category
Medical Device
Distribution
47 states
ModerateFDA (Devices)·Z-0163-2022·2021-11-03
Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number
Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.
Product
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0168-2022·2021-11-03
GORE CARDIOFORM Septal Occluder Labeled with Incorrect Expiration Date
W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.
Product
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
Category
Medical Device
Distribution
47 states
ModerateFDA (Devices)·Z-0166-2022·2021-11-03
GORE CARDIOFORM Septal Occluders Recalled for Incorrect Expiration Date
W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.
Product
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
Category
Medical Device
Distribution
47 states
ModerateFDA (Devices)·Z-0167-2022·2021-11-03
GORE CARDIOFORM SEPTAL OCCLUDER Recalled for Incorrect Expiration Date Labeling
GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.
Product
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
Category
Medical Device
Distribution
47 states
SevereFDA (Devices)·Z-0091-2022·2021-10-27
Cardiosave Li-Ion battery pack recalled for insufficient runtime specification
Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.
Product
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0107-2022·2021-10-27
Infusion Pump Air Detector Malfunction May Prevent Alarm to Clinician
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.
Product
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k.…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0147-2022·2021-10-27
Central Line Dressing Kit Component Has Shorter Expiration Than Kit Label
Medical Action Industries recalls Central Line Dressing Change kits because the ChloraPrep 3ml component expires sooner than the kit label indicates. Users should discontinue use and contact their supplier.
Product
Kit: Central Line Dres Change 20/Cs
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0122-2022·2021-10-27
MPR Slotted Mallet recalled for potential head separation
Implant Resource Inc is recalling the MPR Slotted Mallet (Model MPR-1120-1000, Lot 200911-1-1) due to potential separation of the mallet head from the handle and unexpected deformations on the striking surface.
Product
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0140-2022·2021-10-27
MRI system software may produce incomplete 3D images
GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Product
Optima MR450w 1.5T nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-0125-2022·2021-10-27
Siemens Atellica IM 1600 Analyzer Recalled for Reagent Overflow at High Altitude
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 analyzers that may leak reagent when located at altitudes above 350 meters, potentially causing testing errors.
Product
Atellica IM 1600 Analyzer, SMN 11066000
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0162-2022·2021-10-27
COVID-19 Diagnostic Control Pack Recalled for Unapproved Raw Materials
DiaSorin Molecular is recalling the SIMPLEXA COVID-19 Positive Control Pack due to unapproved raw materials in manufacturing that may cause delayed amplification signals during testing.
Product
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0152-2022·2021-10-27
Smiths Medical Portex Loss of Resistance Device Lacks Sterilization and Reuse Labeling
Smiths Medical ASD Inc. is recalling the Portex Loss of Resistance Device because product labeling lacks information on sterilization procedures and does not prohibit reuse. The recall affects 3,420 devices distributed internationally.
Product
smiths medical portex Loss of Resistance Device, REF 100/398/000
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0128-2022·2021-10-27
IUD Insertion Kit Tenaculum Devices Recalled for Manufacturing Standards Non-Compliance
Stradis Medical recalled 14,959 IUD Insertion Kits nationwide after being unable to confirm the tenaculum devices were manufactured according to required design and manufacturing standards.
Product
IUD Insertion Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0153-2022·2021-10-27
Jamshidi Bone Marrow Biopsy Tray Recalled for Misbranding
Bard Peripheral Vascular Inc is recalling an Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray due to misbranding. A total of 360 devices were distributed to healthcare facilities across multiple U.S. states.
Product
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion.…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0157-2022·2021-10-27
Medtronic Surgical Blades Recalled Due to Tip Breaks and Vibration
Medtronic is recalling surgical blades used in ENT procedures due to increasing complaints of tip breaks and vibration. Approximately 274,991 devices distributed worldwide are affected.
Product
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2022·2021-10-27
medfusion Stopcock devices recalled due to sterility assurance deficiency
Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.
Product
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p.…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0121-2022·2021-10-27
FDA Recalls P2131 Automated Field Steam Sterilizer for Electrical Grounding Defect
Fort Defiance Industries is recalling the P2131 Automated Field Steam Sterilizer because the rear heater assembly lacks sufficient electrical grounding, creating a shock hazard. The recall affects 380 devices distributed nationwide and to Canada.
Product
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2022·2021-10-27
GE SIGNA Artist MRI System May Produce Incomplete Image Scans
GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Product
SIGNA Artist nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-0132-2022·2021-10-27
MRI System Software Defect Causes Missing Image Slices
GE Healthcare is recalling 11 SIGNA Premier MRI systems. Under certain conditions, software versions RX29.1 and RX27.3 can cause missing slices in 3D imaging, creating gaps in anatomical data clinicians use for diagnosis.
Product
SIGNA Premier nuclear magnetic resonance imaging system
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-0146-2022·2021-10-27
Herniatome Surgical Instrument Recalled Due to Sterilization Process Failure
ADRIA SRL recalls Herniatome cervical surgical instruments (Model 5091749) due to sterilization process parameter failures. Products distributed to NJ and NY.
Product
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0131-2022·2021-10-27
IUD Insertion Kit Recalled Over Manufacturing Standards Verification Issues
Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet required design and manufacturing standards.
Product
Standard IUD Insertion Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0161-2022·2021-10-27
Easi-Care Gait Belt Metal Buckle may fail at lower loads than rated
Kinsman Enterprises is recalling approximately 13,123 Easi-Care Gait Belts because the metal buckle may fail at loads below the labeled 600-pound capacity, creating a fall risk for users.
Product
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Category
Medical Device
Distribution
14 states

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13401–13425 of 39988