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

1276–1300 of 13380

SevereFDA (Devices)·Z-0913-2026·2025-12-24
GE Healthcare Carestation anesthesia systems may unexpectedly shut down during power loss
GE Healthcare is recalling Carestation anesthesia systems that may unexpectedly shut down if AC power is lost, potentially disrupting ventilation and anesthetic delivery during surgery.
Product
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2026·2025-12-24
Ivenix Infusion System Software Versions 5.10.1 and Earlier Recalled
Fresenius Kabi is recalling Ivenix Infusion System software versions 5.10.1 and earlier due to software anomalies that could cause serious patient harm or death.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-0915-2026·2025-12-24
GE Carestation anesthesia system shutdown risk during AC power loss
GE Healthcare Carestation 600 and 700 Series anesthesia systems with certain power boards may unexpectedly shut down during AC power loss, with temporary disruption of ventilation and loss of previous settings after reboot.
Product
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0956-2026·2025-12-24
Myosa for Kids mouthguards recalled for missing FDA premarket approval
Myofunctional Research Company USA is recalling 436 Myosa for Kids mouthguards distributed nationwide and in Australia without FDA premarket clearance. The devices are intended for children ages 3-15 to address breathing and myofunctional disorders.
Product
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2026·2025-12-24
Arteriogram Device Recalled Due to Potential Incomplete Header Bag Seal
AVID Medical is recalling Halyard MIDTOWN GENERAL ARTERIOGRAM devices due to potential incomplete seals on header bags that could compromise product sterility. Approximately 300 units (Lot 1635477) were distributed to healthcare facilities in Georgia, Illinois, Nebraska, and Maryland.
Product
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0954-2026·2025-12-24
Rocket Chest Tube Catheter Procedure Trays Recalled Over Improper Securing Risk
Rocket Medical Plc is recalling Rocket 16Fg Seldinger Catheter Procedure Trays because labeling contains misleading statements that may lead to improper device securing, creating a risk it may fall out during use.
Product
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0935-2026·2025-12-24
GE HealthCare ViewPoint 6 radiological imaging software incomplete patient history
The Patient History tab in ViewPoint 6 ultrasound software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.
Product
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0949-2026·2025-12-24
Calf Implants Recalled for Manufacturing Deviations and Lack of FDA Approval
DSAART LLC is recalling AART Calf Implants due to manufacturing deviations from specifications and distribution without required FDA premarket approval. No injuries reported.
Product
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0929-2026·2025-12-24
Halyard surgical pack recalled for incomplete header bag seal
AVID Medical is recalling the Halyard surgical pack due to potential incomplete sealing of the header bag, which may compromise sterility. The recall affects 90 units distributed to healthcare facilities in Georgia, Illinois, Nebraska, and Maryland.
Product
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0951-2026·2025-12-24
Rocket Seldinger Chest Catheter Recall Due to Misleading Securing Instructions
Rocket Medical is recalling the Rocket 12Fg Seldinger Catheter with Safety Guard due to misleading labeling in device kit instructions that may result in improper securing and potential device dislodgement.
Product
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0942-2026·2025-12-24
DTT Reagent for WASP Specimen Processor: Liquification Functionality Not Guaranteed
Copan Italia is recalling DTT reagent for use with the WASP specimen processor because functionality for liquifying respiratory specimens cannot be guaranteed. Approximately 122,850 units were distributed across 14 U.S. states.
Product
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0952-2026·2025-12-24
Rocket 18Fg Chest Tube Recall: Misleading Securing Instructions
Rocket Medical is recalling its 18Fg Seldinger Catheter Procedure Tray due to misleading instructions in device labeling that could lead to improper securing and potential device displacement.
Product
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0944-2026·2025-12-24
AART Silicone Carving Implants Recalled for Specification Deviation and Missing FDA Approval
DSAART LLC is recalling AART Silicone Carving Implants across multiple models due to manufacturing deviations from specifications and distribution without required FDA premarket approval. The recall affects 369 implants distributed to 28 U.S. states, Washington D.C., and Puerto Rico.
Product
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carvi
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0950-2026·2025-12-24
Rocket chest tube procedure tray recalled due to misleading labeling
Rocket Medical is recalling the Rocket 12Fg Seldinger Catheter Procedure Tray (635 units) due to misleading labeling that may cause improper securing of the chest tube, risking device fall-out during use.
Product
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0937-2026·2025-12-24
Surgical Navigation Guide Contains Incorrect Instrument Compatibility Information
SeaSpine Orthofix recalls NorthStar OCT Navigation Surgical Technique Guides due to incorrect identification of compatible Medtronic toolcards; only Solera toolcards are compatible, not Infinity toolcards.
Product
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-4001
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-0958-2026·2025-12-24
InPen Insulin App software issue disables notification reminders after reinstall
The InPen App for Android may fail to show notification settings when reinstalled, preventing users from enabling reminders for insulin therapy. This could cause missed insulin doses and blood sugar elevation.
Product
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-0921-2026·2025-12-24
Medline Surgical Scissors Recalled Due to Weak Packaging Seals
Medline Industries is recalling sterile surgical scissors with Item Number DYND04000 due to weak packaging seals that may breach sterility. If the seal fails, there is an increased risk of infection when the product is used.
Product
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2026·2025-12-24
Rocket 18Fg Seldinger Catheter safety guard labeling contains misleading statements causing improper securing
Rocket Medical Plc is recalling the Rocket 18Fg Seldinger Catheter with Safety Guard due to misleading labeling that may result in improper securing and device displacement during use.
Product
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0940-2026·2025-12-24
MADSEN ACCUSCREEN Hearing Test Probe May Produce Inaccurate Results
Certain MADSEN ACCUSCREEN hearing test probes may give false PASS results due to acoustic distortions from a speaker replacement. This could cause actual hearing loss to go undetected.
Product
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0924-2026·2025-12-24
Zimmer Surgical recalls Air Dermatome for control bar misalignment
Zimmer Surgical Inc is recalling 839 units of the Zimmer Air Dermatome Model 00880100100 due to potential misalignment of the thickness control bar, which could affect proper operation during skin grafting procedures.
Product
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0920-2026·2025-12-24
BeneVision Distributed Monitoring System computers may freeze or lose audio
Mindray's BeneVision DMS workstations with specific hardware may experience audio playback failure or screen freezing, affecting patient monitoring capability.
Product
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0930-2026·2025-12-24
AVID Medical Halyard Head and Neck Tray Recalled for Incomplete Seal
AVID Medical is recalling 56 units of the Halyard HEAD AND NECK TRAY due to a potential for incomplete seal on the header bag, which could compromise product sterility. The recall affects units distributed in Georgia, Illinois, Nebraska, and Maryland.
Product
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0960-2026·2025-12-24
Cepheid BCR-ABL Ultra diagnostic test kits recalled for inaccurate results
Cepheid Xpert® BCR-ABL Ultra diagnostic test kits are being recalled because specimens with elevated white blood cell counts (>30,000 cells) may produce inaccurate test results. The recall affects 4,032 units distributed across the US and internationally.
Product
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0927-2026·2025-12-24
Halyard EP LAB Pack recalled for incomplete header bag seal
AVID Medical is recalling 240 units of Halyard EP LAB Pack (Catalog ESJH009-03) due to potential incomplete seals on header bags. The affected lot was distributed to facilities in Georgia, Illinois, Nebraska, and Maryland.
Product
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0936-2026·2025-12-24
Fresenius 5008X CAREsystem Dialysis Device Recalled Due to Software Defects
Fresenius Medical Care is recalling 115 units of the 5008X CAREsystem dialysis device due to software anomalies that could interrupt patient treatment. The defect may cause the device to stop operating under certain conditions.
Product
5008X CAREsystem +CLiC +CDX;
Category
Medical Device
Distribution
3 states

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1276–1300 of 13380