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

8501–8525 of 40056

SevereFDA (Devices)·Z-0515-2024·2023-12-27
Sterile Water Syringes recalled for lack of sterility assurance
Nurse Assist LLC recalls sterile water injection and irrigation syringes for inadequate sterility assurance. Affected products may be nonsterile and could cause infection if used.
Product
Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0539-2024·2023-12-27
AirFit N20 Nasal Mask: Magnetic Interference with Medical Implants
ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.
Product
AirFit N20 Nasal Mask and User Guide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0541-2024·2023-12-27
AirFit F30 Full Face Mask recalled for magnetic interference with medical implants
ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.
Product
AirFit F30 Full Face Mask and User Guide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0538-2024·2023-12-27
AirTouch F20 Full Face Mask Recalled for Magnetic Interference with Medical Implants
ResMed recalls 3.8 million AirTouch F20 full face masks with magnets that may interfere with active medical implants. Updated safety warnings regarding safe distances from medical devices are being issued.
Product
AirTouch F20 Full Face Mask and User Guide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0512-2024·2023-12-27
Sodium Chloride IV Flush Kits Recalled for Potential Sterility Failure
Nurse Assist recalls sodium chloride IV flush solutions due to potential loss of sterility assurance. Nonsterile solutions could cause infection when used for intravenous administration.
Product
0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0514-2024·2023-12-27
Sterile Water and Saline Products Recalled for Lack of Sterility Assurance
Nurse Assist is recalling sterile water and saline irrigation products due to lack of sterility assurance. Use of nonsterile products could result in infection.
Product
Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0537-2024·2023-12-27
AirFit F20 Full Face Mask recalled for magnetic interference with medical implants
ResMed is recalling AirFit F20 Full Face Masks due to magnets that can interfere with active medical implants. Updated warnings will guide safe distances for patients and those in close contact.
Product
AirFit F20 Full Face Mask and User Guide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0540-2024·2023-12-27
AirTouch N20 Nasal Mask recalled for magnetic interference with medical implants
ResMed is recalling 424,309 units of AirTouch N20 Nasal Masks because they contain magnets that may interfere with active medical implants and ferromagnetic materials. Updated safety warnings are being provided.
Product
AirTouch N20 Nasal Mask and User Guide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0542-2024·2023-12-27
AirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk
ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.
Product
AirFit F30i Full Face Mask and User Guide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0536-2024·2023-12-27
ResMed AirFit N10 Nasal Masks Recalled for Magnetic Interference with Medical Implants
ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.
Product
AirFit N10 Nasal Masks and User Guide
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0604-2024·2023-12-27
Abbott Hematology Analyzers Recalled for Unlabeled Latex Component
Abbott CELL-DYN Ruby and Sapphire hematology analyzers contain latex that is not labeled on the device, posing a risk to users with latex allergies. The recall affects 670 devices distributed across 33 states, Puerto Rico, and Brazil.
Product
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0605-2024·2023-12-27
Venous probe connection cable defects in Cardiohelp-i extracorporeal support systems
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Product
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0588-2024·2023-12-27
Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Product
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0573-2024·2023-12-27
Injection Needles Recalled for Inadequate Manual Cleaning Process
Karl Storz is recalling 1,127 injection needles used in general and visceral surgery because the manual cleaning process cannot be adequately assured, potentially increasing infection risk for patients.
Product
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0584-2024·2023-12-27
Exactech Optetrak Logic PS Knee System Vacuum Loss Recall
Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.
Product
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0577-2024·2023-12-27
AcuMatch Hip System Recalled for Loss of Vacuum Integrity
Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.
Product
AcuMatch Hip System, Catalog Number 142-32-27
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0587-2024·2023-12-27
Exactech Vantage Ankle System Recalled Due to Vacuum Loss
Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.
Product
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0575-2024·2023-12-27
Surgical Injection Needles Recalled for Uncertain Manual Cleaning Efficacy
Karl Storz Endoscopy injection needles used in surgery may not be reliably cleaned by hand, exposing patients to higher infection risk. The recall affects 4,878 units.
Product
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0581-2024·2023-12-27
Exactech Novation Hip System Recalled for Vacuum Seal Loss
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Product
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0574-2024·2023-12-27
Injection needles recalled due to cleaning efficacy concerns
Karl Storz Endoscopy is recalling injection needles used in general and visceral surgery due to concerns that the manual cleaning process cannot ensure adequate sterilization, which may increase infection risk.
Product
Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0579-2024·2023-12-27
Exactech Equinoxe Shoulder System recalled for vacuum loss in bags
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
Product
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0582-2024·2023-12-27
Exactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure
Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.
Product
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0580-2024·2023-12-27
Exactech Equinoxe Shoulder System recalled for loss of vacuum
Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.
Product
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0565-2024·2023-12-27
CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination
CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
Product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0578-2024·2023-12-27
Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag
Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.
Product
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Category
Medical Device
Distribution
16 states

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8501–8525 of 40056